Drugs / Dupilumab
Regulatory milestones approvals, filings & regulatory actions · 45 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed asthma 6 milestones | |||||
| Filed | EU (EMA) | Dupixent | asthma | 2021-04-28 | “Also, the European Medicines Agency (EMA) has confirmed receipt of the submission for Dupixent ® in children with moderate-to-severe asthma.” sanofi.com ↗ “A regulatory application for Dupixent for children aged 6 to 11 years with severe asthma was also submitted in the European Union (EU).” regeneron.com ↗ |
| Filed | US (FDA) | Dupixent | asthma | 2021-04-28 | “An sBLA for asthma in patients aged 12 and over was submitted with the FDA in the fourth quarter of 2017.” regeneron.com ↗ “accepted for review, with a target action date of October 21, 2021, the sBLA for Dupixent” regeneron.com ↗ “The FDA accepted Dupixent ® for review in children with moderate-to-severe asthma.” sanofi.com ↗ |
| Filed | US (FDA) | Dupixent | asthma | 2021-03-04 | “FDA has accepted for review the supplemental Biologics License Application (sBLA) for Dupixent ® (dupilumab)” regeneron.com ↗ “FDA has accepted for review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab)” regeneron.com ↗ |
| Filed | EU (EMA) | DUPIXENT | asthma | 2018-04-03 | “accepted for review by the European Medicines Agency (EMA) and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan for Dupixent in asthma.” regeneron.com ↗ “the European Medicines Agency (EMA) has accepted for review an application for DUPIXENT® (dupilumab)” regeneron.com ↗ |
| Filed | US (FDA) | DUPIXENT | asthma | 2018-03-02 | “FDA has accepted for review the supplemental Biologics License Application (sBLA) of DUPIXENT® (dupilumab)” regeneron.com ↗ |
| Filed | Japan (PMDA) | DUPIXENT | asthma | — | “accepted for review by the European Medicines Agency (EMA) and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan for Dupixent in asthma.” regeneron.com ↗ |
| Filed atopic eczema 3 milestones | |||||
| Filed | US (FDA) | Dupixent | atopic eczema | 2022-04-28 | “The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent ®” sanofi.com ↗ |
| Filed | US (FDA) | Dupixent | atopic eczema | 2020-01-28 | “The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent ® (dupilumab)” regeneron.com ↗ “The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab)” regeneron.com ↗ “The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent ®” regeneron.com ↗ “FDA has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab)” regeneron.com ↗ |
| Filed | EU (EMA) | Dupixent | atopic eczema | — | “A regulatory filing for this age group is under review by the European Medicines Agency” sanofi.com ↗ |
| Filed bronchiectasis and nasal polyposis 4 milestones | |||||
| Filed | US (FDA) | Dupixent | bronchiectasis and nasal polyposis | 2024-05-13 | “FDA has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab)” regeneron.com ↗ |
| Filed | US (FDA) | Dupixent | bronchiectasis and nasal polyposis | 2019-05-07 | “The FDA accepted for priority review the sBLA for Dupixent as an add-on maintenance treatment for adults” regeneron.com ↗ |
| Filed | EU (EMA) | Dupixent | bronchiectasis and nasal polyposis | 2019-05-07 | “The Company and Sanofi have also submitted a European Marketing Authorization Application (MAA) for CRSwNP.” regeneron.com ↗ |
| Filed | US (FDA) | Dupixent | bronchiectasis and nasal polyposis | 2019-03-08 | “FDA has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab)” regeneron.com ↗ |
| Filed bullous pemphigoid 1 milestone | |||||
| Filed | US (FDA) | Dupixent | bullous pemphigoid | 2025-02-04 | “In February, the U.S. Food and Drug Administration (FDA) accepted for Priority Review the supplemental Biologics License Application for Dupixent to treat BP.” regeneron.com ↗ “In February, the US Food and Drug Administration (FDA) accepted for priority review the supplemental biologics license application for Dupixent to treat BP.” sanofi.com ↗ “An sBLA for Dupixent in bullous pemphigoid was submitted to the FDA.” regeneron.com ↗ |
| Filed chronic idiopathic urticaria 4 milestones | |||||
| Filed | US (FDA) | Dupixent | chronic idiopathic urticaria | 2026-02-27 | “a supplemental Biologics License Application (sBLA) has been accepted for review seeking approval for Dupixent in certain children aged 2 to 11 years with CSU.” regeneron.com ↗ “the supplemental Biologics License Application (sBLA) for Dupixent has been accepted for review in certain children aged 2 to 11 years with CSU.” regeneron.com ↗ “the supplemental biologics license application for Dupixent has been accepted for review in certain children aged two to 11 years with CSU.” sanofi.com ↗ |
| Filed | US (FDA) | Dupixent | chronic idiopathic urticaria | 2024-11-15 | “FDA has accepted for review the resubmission of the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab)” regeneron.com ↗ “Dupixent sBLA accepted for FDA review for the treatment of chronic spontaneous urticaria” sanofi.com ↗ |
| Rejected (CRL) | US (FDA) | Dupixent | chronic idiopathic urticaria | 2023-10-20 | “FDA) has issued a Complete Response Letter (CRL) for the supplemental Biologics License Application (sBLA) for Dupixent ® (dupilumab) in chronic spontaneous urticaria (CSU).” regeneron.com ↗ “FDA) has issued a Complete Response Letter (CRL) for the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) in chronic spontaneous urticaria (CSU).” regeneron.com ↗ “In October 2023, the FDA issued a Complete Response Letter (CRL) for the sBLA for Dupixent in chronic spontaneous urticaria (CSU).” regeneron.com ↗ |
| Filed | US (FDA) | Dupixent | chronic idiopathic urticaria | 2023-03-07 | “Dupixent ® (dupilumab) application for treatment of chronic spontaneous urticaria (CSU) in adults and adolescents accepted for FDA review” sanofi.com ↗ |
| Filed chronic obstructive pulmonary disease 4 milestones | |||||
| Filed | US (FDA) | Dupixent | chronic obstructive pulmonary disease | 2024-02-23 | “Dupixent sBLA for chronic obstructive pulmonary disease (COPD) with type 2 inflammatory phenotype and linvoseltamab BLA for multiple myeloma submitted to FDA” regeneron.com ↗ “The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent” sanofi.com ↗ “Dupixent submitted for COPD (Chronic Obstructive Pulmonary Disease) in the U.S., EU, and China” sanofi.com ↗ |
| Filed | China (NMPA) | Dupixent | chronic obstructive pulmonary disease | — | “Dupixent submitted for COPD (Chronic Obstructive Pulmonary Disease) in the U.S., EU, and China” sanofi.com ↗ “Regulatory submissions are also under review in China and the European Union.” sanofi.com ↗ |
| Filed | Japan (PMDA) | Dupixent | chronic obstructive pulmonary disease | — | “A regulatory application is also under review in the European Union (EU) and Japan.” regeneron.com ↗ |
| Filed | EU (EMA) | Dupixent | chronic obstructive pulmonary disease | — | “The European Medicines Agency is reviewing Sanofi and Regeneron’s application for Dupixent for the treatment of uncontrolled COPD with type 2 inflammation” sanofi.com ↗ “The European Medicines Agency is reviewing Regeneron and Sanofi’s application for Dupixent for the treatment of uncontrolled COPD with type 2 inflammation” regeneron.com ↗ “Dupixent submitted for COPD (Chronic Obstructive Pulmonary Disease) in the U.S., EU, and China” sanofi.com ↗ “A regulatory application is also under review in the European Union (EU) and Japan.” regeneron.com ↗ “Regulatory submissions are also under review in China and the European Union.” sanofi.com ↗ |
| Filed eosinophilic angiocentric fibrosis 1 milestone | |||||
| Filed | US (FDA) | Dupixent | eosinophilic angiocentric fibrosis | — | “FDA accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent in adults and children aged 6 years and older with AFRS.” regeneron.com ↗ “FDA accepted for priority review the supplemental biologics license application (sBLA) for Dupixent in adults and children aged 6 years and older with AFRS.” regeneron.com ↗ “These data formed the basis for a supplemental Biologics License Application (sBLA) in the U.S., which is currently under Priority Review” regeneron.com ↗ |
| Filed eosinophilic esophagitis 1 milestone | |||||
| Filed | US (FDA) | Dupixent | eosinophilic esophagitis | 2022-04-04 | “The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent ® (dupilumab)” regeneron.com ↗ “the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab)” regeneron.com ↗ “The FDA accepted for priority review the supplemental Biologics License Application (sBLA) for the treatment of children aged 1 to 11 years with EoE” regeneron.com ↗ “accepted for Priority Review the supplemental Biologics License Application for higher dose Dupixent to treat children aged 1 to 11 years with EoE” sanofi.com ↗ “The FDA has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent ® 300 mg weekly” sanofi.com ↗ |
| Filed prurigo nodularis 4 milestones | |||||
| Filed | Japan (PMDA) | Dupixent | prurigo nodularis | 2022-08-03 | “Regulatory applications have also been submitted in the European Union (EU) and Japan.” regeneron.com ↗ |
| Filed | EU (EMA) | Dupixent | prurigo nodularis | 2022-08-03 | “Regulatory applications have also been submitted in the European Union (EU) and Japan.” regeneron.com ↗ |
| Filed | US (FDA) | Dupixent | prurigo nodularis | 2022-07-28 | “The FDA accepted for priority review the supplemental Biologics License Application (sBLA) for Dupixent for adults with prurigo nodularis” regeneron.com ↗ “FDA accepted Dupixent ® for priority review in adults with prurigo nodularis” sanofi.com ↗ |
| Filed | US (FDA) | Dupixent | prurigo nodularis | 2022-05-31 | “FDA has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® Medical (dupilumab) to treat adults with prurigo nodularis” regeneron.com ↗ “FDA has accepted for priority review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) to treat adults with prurigo nodularis” sanofi.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (15) | US (FDA) | DUPIXENT | — | 2018-04-10 – 2026-04-22 | fda.gov ↗ |
| Approved | EU (EMA) | Dupixent | — | 2017-09-26 | europa.eu ↗ |
| Approved | US (FDA) | DUPIXENT | — | 2017-03-28 | fda.gov ↗ |
Trials 174 · started per year
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 05 trials | ||||||
| Phase 0 | NCT06637306 | Mar 2025 → Mar 2027 expected | triple-negative breast carcinoma | Rima Patel | Recruiting | No outcome recorded |
| Phase 0 | NCT05649098 | Jun 2023 → Jun 2031 expected | skin disorder | Northwestern University | Recruiting | No outcome recorded |
| Phase 0 | NCT05372003 | Aug 2022 → Feb 2024 | atopic eczema | Mayo Clinic | Completed | No outcome recorded |
| Phase 0 | NCT04943744 | May 2021 → May 2024 | eosinophil disorder, food allergy | Stanford University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 0 | NCT03675022 | Aug 2018 → Jul 2022 | chronic rhinosinusitis, obstructive sleep apnea syndrome | Brigham and Women's Hospital | Terminated | No outcome recorded Stop: Enrollment |
| Phase 113 trials | ||||||
| Phase 1 | NCT07646548 | Jun → Sep 2026 overdue | — | Sanofi | Recruiting | No outcome recorded |
| Phase 1 | NCT05976386 | Jun → Sep 2021 | — | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT03112577 | Jun 2017 → Mar 2019 | allergic asthma | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT03050151 | Feb → Nov 2017 | atopic IgE-mediated allergic disorder, atopic eczema | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02647086 | Dec 2015 → Jul 2016 | atopic eczema | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT05976373 | Jan → Mar 2015 | — | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT05976360 | Nov 2014 → Jan 2015 | — | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT01537653 | Mar → Oct 2012 | — | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT01537640 | Feb → Jul 2012 | — | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT01484600 | Dec 2011 → Feb 2012 | — | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01385657 | Jul 2011 → Mar 2012 | atopic eczema | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01259323 | Dec 2010 → Jul 2012 | dermatitis | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01015027 | Oct 2009 → Jul 2010 | — | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT07277322 | Jun 2026 → Dec 2028 expected | metastasis from malignant tumor of colon | Dan Feng | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06088771 | Mar 2024 → Apr 2026 overdue | non-small cell lung carcinoma | Icahn School of Medicine at Mount Sinai | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05013450 | Sep 2021 → Sep 2025 overdue | non-small cell lung carcinoma | Thomas Marron | Active not recruiting | No outcome recorded |
| Phase 243 trials · 11 met primary · 4 missed | ||||||
| Phase 2 | NCT07330934 | Dec 2025 → Jun 2027 expected | atopic eczema | Innovent Biologics (Suzhou) Co. Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT07091175 | Nov 2025 → Feb 2028 expected | nephrotic syndrome | National University Hospital, Singapore | Recruiting | No outcome recorded |
| Phase 2 | NCT06477653 | Feb 2025 → Dec 2026 expected | hypereosinophilic syndrome | National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting | No outcome recorded |
| Phase 2 | NCT05866562 | Jul 2024 → Mar 2029 expected | alopecia areata | Icahn School of Medicine at Mount Sinai | Recruiting | No outcome recorded |
| Phase 2 | NCT05031455 | Mar 2024 → Apr 2026 | aspirin-induced respiratory disease | Scripps Clinic | Completed | No outcome recorded |
| Phase 2 | NCT05967884 | Aug 2023 → Aug 2024 | breast cancer | Ottawa Hospital Research Institute | Unknown | No outcome recorded |
| Phase 2 | NCT05575037 | Aug 2023 → Apr 2026 overdue | aspirin-induced respiratory disease, asthma, nasal polyps, and aspirin intolerance, nasal cavity polyp | Brigham and Women's Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05831176 | May 2023 → Feb 2026 overdue | eosinophilic gastritis | Regeneron Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05551793 | Apr 2023 → Nov 2027 expected | alopecia areata | Emma Guttman | Recruiting | No outcome recorded |
| Phase 2 | NCT05720325 | Mar 2023 → Nov 2026 expected | allergic asthma | The University of Texas Health Science Center at San Antonio | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05128383 | Jan 2023 → May 2025 | keloid | Beth Israel Deaconess Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT05731128 | Jan 2023 → May 2026 overdue | ulcerative colitis | Sanofi | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05347771 | May 2022 → Dec 2026 expected | asthma | National Institute of Allergy and Infectious Diseases (NIAID) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04148352 | Oct 2021 → Dec 2024 | food allergy | Andrew J Long, PharmD | Terminated | No outcome recorded |
| Phase 2 | NCT04920916 | May 2021 → Apr 2023 | COVID-19 | University of Virginia | Completed | Missed primary |
| Phase 2 | NCT04600362 | Mar 2021 → Sep 2025 overdue | — | Technical University of Munich | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04502966 | Nov 2020 → Feb 2025 | seasonal allergic rhinitis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Met primary |
| Phase 2 | NCT04362501 | Oct 2020 → Sep 2025 | chronic rhinosinusitis | Johns Hopkins University | Completed | No outcome recorded |
| Phase 2 | NCT04442269 | Sep 2020 → Jul 2023 | allergic bronchopulmonary aspergillosis | Regeneron Pharmaceuticals | Completed | Met primary |
| Phase 2 | NCT04256759 | Sep 2020 → Sep 2024 | — | Mayo Clinic | Completed | No outcome recorded |
| Phase 2 | NCT04200755 | May 2020 → Nov 2023 | localized scleroderma | University of Cologne | Completed | No outcome recorded |
| Phase 2 | NCT04296864 | Feb 2020 → Jan 2025 | atopic keratoconjunctivitis | Andover Eye Associates | Unknown | No outcome recorded |
| Phase 2 | NCT03679676 | Feb 2020 → Apr 2025 | food allergy, insect Stings, hypersensitivity to | Stanford University | Completed | Missed primary |
| Phase 2 | NCT03886493 | Aug 2019 → Oct 2020 | prostate cancer | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03861455 | Jul 2019 → Nov 2023 | — | University Hospital, Toulouse | Completed | No outcome recorded |
| Phase 2 | NCT03793608 | Mar 2019 → Feb 2021 | food allergy | Regeneron Pharmaceuticals | Completed | Missed primary |
| Phase 2 | NCT03736967 | Nov 2018 → Mar 2020 | atopic eczema | Regeneron Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT03682770 | Oct 2018 → Oct 2020 | food allergy | Regeneron Pharmaceuticals | Completed | Met primary |
| Phase 2 | NCT03595488 | Sep 2018 → Dec 2019 | aspirin-induced respiratory disease | Rochester General Hospital | Completed | No outcome recorded |
| Phase 2 | NCT03558997 | Jun 2018 → May 2019 | allergic rhinitis | Regeneron Pharmaceuticals | Completed | Missed primary |
| Phase 2 | NCT03387852 | Mar 2018 → Mar 2019 | asthma | Sanofi | Completed | Mixed |
| Phase 2 | NCT03359356 | Jan 2018 → Jan 2020 | alopecia areata | Icahn School of Medicine at Mount Sinai | Completed | Met primary |
| Phase 2 | NCT02573233 | Jan 2016 → Jan 2018 | asthma | Sanofi | Completed | Mixed |
| Phase 2 | NCT02379052 | May 2015 → Feb 2017 | eosinophilic esophagitis | Regeneron Pharmaceuticals | Completed | Met primary |
| Phase 2 | NCT02407756 | Mar 2015 → Mar 2016 | atopic eczema | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02210780 | Aug 2014 → Sep 2015 | atopic eczema | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01979016 | Dec 2013 → Dec 2014 | atopic eczema | Regeneron Pharmaceuticals | Completed | Met primary |
| Phase 2 | NCT01920893 | Aug 2013 → Nov 2014 | nasal cavity polyp | Sanofi | Completed | Met primary |
| Phase 2 | NCT01854047 | Jun 2013 → Nov 2014 | asthma | Sanofi | Completed | Met primary |
| Phase 2 | NCT01859988 | May 2013 → May 2014 | atopic eczema | Regeneron Pharmaceuticals | Completed | Met primary |
| Phase 2 | NCT01639040 | Jul → Dec 2012 | atopic eczema | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01548404 | Apr 2012 → Mar 2013 | atopic eczema | Regeneron Pharmaceuticals | Completed | Met primary |
| Phase 2 | NCT01312961 | Mar 2011 → Oct 2012 | asthma | Sanofi | Completed | Met primary |
| Phase 2/34 trials · 2 met primary | ||||||
| Phase 2/3 | NCT05535738 | Nov 2022 → Jan 2027 expected | allergic contact dermatitis | Wei-Che Ko | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT04206553 | Oct 2020 → Jul 2024 | bullous pemphigoid | Regeneron Pharmaceuticals | Completed | Met primary |
| Phase 2/3 | NCT04244006 | Jul 2020 → Jun 2022 | Netherton syndrome | University Hospital, Toulouse | Terminated | No outcome recorded |
| Phase 2/3 | NCT03346434 | Nov 2017 → Jul 2021 | atopic eczema | Regeneron Pharmaceuticals | Completed | Met primary |
| Phase 347 trials · 25 met primary · 1 missed | ||||||
| Phase 3 | NCT07309614 | Jan 2026 → Jan 2029 expected | asthma | University of Sherbrooke | Recruiting | No outcome recorded |
| Phase 3 | NCT07112378 | Nov 2025 → Jun 2028 expected | eosinophilic esophagitis | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT06687967 | Nov 2024 → Jun 2026 | neurodermatitis | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT06687980 | Nov 2024 → Jun 2026 | neurodermatitis | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT06461897 | Aug 2024 → Jul 2030 expected | atopic eczema | AbbVie | Recruiting | No outcome recorded |
| Phase 3 | NCT06461949 | Jul 2024 | asthma, chronic rhinosinusitis, nasal cavity polyp | National Institute on Deafness and Other Communication Disorders (NIDCD) | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT06389136 | Jun 2024 → Aug 2026 overdue | atopic eczema | AbbVie | Recruiting | No outcome recorded |
| Phase 3 | NCT06293053 | May 2024 → Oct 2027 expected | prurigo nodularis | Sanofi | Recruiting | No outcome recorded |
| Phase 3 | NCT06191315 | Jan 2024 → Dec 2028 expected | asthma | Sanofi | Recruiting | No outcome recorded |
| Phase 3 | NCT05545072 | Oct 2023 → Jul 2024 | chronic rhinosinusitis | Emory University | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT05878093 | May 2023 → Sep 2024 | chronic rhinosinusitis | Sanofi | Completed | Met primary |
| Phase 3 | NCT05601882 | Nov 2022 → Mar 2024 | atopic eczema | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT05526521 | Aug 2022 → Nov 2024 | chronic idiopathic urticaria | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT05263206 | Feb 2022 → Jun 2027 expected | — | Sanofi | Recruiting | No outcome recorded |
| Phase 3 | NCT04417894 | Apr 2021 → Aug 2022 | atopic eczema | Regeneron Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT04678882 | Jan → Dec 2021 | atopic eczema | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT04681729 | Dec 2020 → Feb 2023 | cold urticaria | Sanofi | Completed | Missed primary |
| Phase 3 | NCT04678856 | Dec 2020 → Nov 2023 | chronic rhinosinusitis | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT04684524 | Dec 2020 → Dec 2024 | chronic rhinosinusitis | Sanofi | Completed | Met primary |
| Phase 3 | NCT04394351 | Sep 2020 → Jun 2022 | eosinophilic esophagitis | Regeneron Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT04456673 | Jul 2020 → Feb 2024 | chronic obstructive pulmonary disease | Sanofi | Completed | Met primary |
| Phase 3 | NCT04345367 | Jun 2020 → Jul 2021 | atopic eczema | Pfizer | Completed | Met primary |
| Phase 3 | NCT04202679 | Jan 2020 → Aug 2021 | neurodermatitis | Sanofi | Completed | Met primary |
| Phase 3 | NCT04183335 | Dec 2019 → Nov 2021 | neurodermatitis | Sanofi | Completed | Met primary |
| Phase 3 | NCT04180488 | Dec 2019 → Aug 2024 | chronic idiopathic urticaria | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT03930732 | Apr 2019 → Feb 2023 | chronic obstructive pulmonary disease | Sanofi | Completed | Met primary |
| Phase 3 | NCT03738397 | Feb 2019 → Aug 2020 | atopic eczema | AbbVie | Completed | Met primary |
| Phase 3 | NCT03782532 | Jan 2019 → May 2022 | asthma | Sanofi | Completed | Met primary |
| Phase 3 | NCT03912259 | Dec 2018 → Feb 2020 | atopic eczema | Sanofi | Completed | Met primary |
| Phase 3 | NCT03633617 | Sep 2018 → Sep 2021 | eosinophilic esophagitis | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT03620747 | Aug 2018 → Feb 2022 | asthma | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT03560466 | Jun 2018 → Apr 2025 | asthma | Sanofi | Completed | Met primary |
| Phase 3 | NCT03345914 | Nov 2017 → Jun 2019 | atopic eczema | Regeneron Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT02948959 | Apr 2017 → Aug 2020 | asthma | Sanofi | Completed | Met primary |
| Phase 3 | NCT03054428 | Mar 2017 → Apr 2018 | atopic eczema | Regeneron Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT02912468 | Dec 2016 → Jul 2018 | chronic rhinosinusitis | Sanofi | Completed | Met primary |
| Phase 3 | NCT02898454 | Nov 2016 → Aug 2018 | chronic rhinosinusitis | Sanofi | Completed | Met primary |
| Phase 3 | NCT02755649 | Jan 2016 → Jan 2017 | atopic eczema | Regeneron Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT02612454 | Oct 2015 → Oct 2026 expected | atopic eczema | Regeneron Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02528214 | Oct 2015 → Sep 2017 | asthma | Sanofi | Completed | Met primary |
| Phase 3 | NCT02414854 | Apr 2015 → Jul 2017 | asthma | Sanofi | Completed | Met primary |
| Phase 3 | NCT02395133 | Mar 2015 → Jul 2016 | atopic eczema | Regeneron Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT02277769 | Nov 2014 → Oct 2015 | atopic eczema | Regeneron Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT02277743 | Oct 2014 → Nov 2015 | atopic eczema | Regeneron Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT02260986 | Sep 2014 → Aug 2015 | atopic eczema | Regeneron Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT02134028 | Aug 2014 → Oct 2019 | asthma | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT01949311 | Oct 2013 → Jun 2022 | atopic eczema | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 453 trials · 2 met primary · 3 missed | ||||||
| Phase 4 | NCT07352566 | Aug 2026 → Jun 2030 expected | atopic eczema, psoriasis | University of California, San Francisco | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07587658 | Jun 2026 → Jul 2028 expected | chronic obstructive pulmonary disease | Regeneron Pharmaceuticals | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06818019 | Dec 2025 → Dec 2027 expected | asthma | University Hospital, Toulouse | Recruiting | No outcome recorded |
| Phase 4 | NCT07187089 | Nov 2025 → Dec 2027 | atopic eczema | Regeneron Pharmaceuticals | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT07053423 | Sep 2025 → Dec 2028 expected | chronic obstructive pulmonary disease | Sanofi | Recruiting | No outcome recorded |
| Phase 4 | NCT06665971 | Nov 2024 → Sep 2026 overdue | eosinophilic esophagitis | University of California, San Diego | Recruiting | No outcome recorded |
| Phase 4 | NCT06572228 | Aug 2024 → Apr 2027 expected | asthma | Regeneron Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05042258 | Aug 2024 → Jun 2027 expected | atopic eczema, sleep disorder | Northwestern University | Recruiting | No outcome recorded |
| Phase 4 | NCT06188871 | Jun 2024 → Jun 2026 | chronic rhinosinusitis | University of Rochester | Withdrawn | No outcome recorded |
| Phase 4 | NCT06352073 | May 2024 → Apr 2026 overdue | eosinophilic esophagitis | University of North Carolina, Chapel Hill | Active not recruiting | No outcome recorded |
| Phase 4 | NCT06116526 | Apr 2024 → Apr 2027 expected | atopic eczema | Johns Hopkins University | Recruiting | No outcome recorded |
| Phase 4 | NCT05983068 | Feb 2024 → Apr 2027 expected | atopic eczema | Sanofi | Active not recruiting | No outcome recorded |
| Phase 4 | NCT06101095 | Nov 2023 → Nov 2025 overdue | eosinophilic esophagitis | Sanofi | Active not recruiting | No outcome recorded |
| Phase 4 | NCT06012448 | Oct 2023 → Jan 2025 | hypersensitivity reaction disease | University of Michigan | Completed | No outcome recorded |
| Phase 4 | NCT06366932 | Sep 2023 → Sep 2025 | atopic eczema | Instituto de Investigación Hospital Universitario La Paz | Unknown | No outcome recorded |
| Phase 4 | NCT06004986 | Aug 2023 → Oct 2025 overdue | atopic eczema | Academic Medical Center - University of Amsterdam | Recruiting | No outcome recorded |
| Phase 4 | NCT05964465 | Aug 2023 → Jan 2025 | chronic rhinosinusitis | Medical University of South Carolina | Completed | No outcome recorded |
| Phase 4 | NCT05642208 | Mar 2023 → Aug 2026 | atopic eczema | Nantes University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT05680298 | Feb → Dec 2023 | atopic eczema | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT05858619 | Feb 2023 → Feb 2028 expected | atopic eczema | University of California, San Francisco | Recruiting | No outcome recorded |
| Phase 4 | NCT05268107 | Jan 2023 → Dec 2026 expected | atopic eczema | University of Michigan | Recruiting | No outcome recorded |
| Phase 4 | NCT05590585 | Jan 2023 → Nov 2024 | atopic eczema | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT05624112 | Nov 2022 → Jan 2024 | atopic eczema | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT05436535 | Nov 2022 → Apr 2025 | atopic eczema | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 4 | NCT05094570 | Sep 2022 → Jun 2026 overdue | nasal cavity polyp, staphylococcus aureus infection | University of Virginia | Recruiting | No outcome recorded |
| Phase 4 | NCT05247866 | Jun 2022 → Jan 2025 | eosinophilic esophagitis | Children's Hospital of Philadelphia | Completed | No outcome recorded |
| Phase 4 | NCT05285839 | Apr 2022 → Dec 2024 overdue | atopic eczema | Psoriasis Treatment Center of Central New Jersey | Recruiting | No outcome recorded |
| Phase 4 | NCT05265234 | Mar 2022 → Mar 2023 | atopic eczema | OptiSkin Medical | Unknown | No outcome recorded |
| Phase 4 | NCT05036733 | Feb 2022 → Jun 2023 | asthma | University of Michigan | Completed | No outcome recorded |
| Phase 4 | NCT05097287 | Dec 2021 → Mar 2027 expected | asthma | Sanofi | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04895423 | Nov 2021 → Jul 2023 | atopic eczema | National Medical Research Center for Children's Health, Russian Federation | Unknown | No outcome recorded |
| Phase 4 | NCT05049122 | Oct 2021 → Dec 2022 | chronic rhinosinusitis | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT06750471 | Oct 2021 → Dec 2025 overdue | chronic rhinosinusitis, nasal cavity polyp | Madigan Army Medical Center | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04998604 | Sep 2021 → Oct 2024 | asthma, chronic rhinosinusitis | Sanofi | Completed | Met primary |
| Phase 4 | NCT03694158 | Sep 2021 → Jan 2027 expected | asthma | Boston Children's Hospital | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04869436 | Jul 2021 → Sep 2026 | chronic rhinosinusitis, olfactory nerve disorder | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Completed | No outcome recorded |
| Phase 4 | NCT04596189 | May 2021 → Apr 2024 | chronic rhinosinusitis | University of Montreal Hospital Centre (CHUM) | Completed | No outcome recorded |
| Phase 4 | NCT04988022 | May 2021 → Mar 2025 | keloid | Icahn School of Medicine at Mount Sinai | Completed | No outcome recorded |
| Phase 4 | NCT04823130 | Apr 2021 → Jun 2022 | atopic eczema | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT04996485 | Mar 2021 → Mar 2023 | inherited ichthyosis | National Medical Research Center for Children's Health, Russian Federation | Unknown | No outcome recorded |
| Phase 4 | NCT04718870 | Feb 2021 → Sep 2022 | atopic eczema | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT04520308 | Sep 2020 → Feb 2021 | atopic eczema | Eric Simpson | Unknown | No outcome recorded |
| Phase 4 | NCT04358224 | Sep 2020 → Nov 2022 | atopic eczema | Jonathan A. Bernstein, MD | Completed | No outcome recorded |
| Phase 4 | NCT04502862 | Aug 2020 → Oct 2023 | asthma | Sanofi | Completed | Missed primary |
| Phase 4 | NCT04447417 | Jul 2020 → Jun 2021 | atopic eczema | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT04203797 | Jul 2020 → Jul 2023 | asthma | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT04400318 | Jun 2020 → Jun 2023 | asthma | Sanofi | Completed | Mixed |
| Phase 4 | NCT04442256 | Jun 2020 → Dec 2022 | aspirin-induced respiratory disease | Medical University of Vienna | Unknown | No outcome recorded |
| Phase 4 | NCT03935971 | Dec 2019 → Dec 2024 overdue | allergic contact dermatitis | Brigham and Women's Hospital | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04033367 | Aug 2019 → Oct 2021 | atopic eczema | Sanofi | Completed | Missed primary |
| Phase 4 | NCT03667014 | Nov 2018 → Dec 2022 | atopic eczema | University of California, San Francisco | Completed | Missed primary |
| Phase 4 | NCT03293030 | Oct 2018 → Feb 2023 | atopic eczema | University of California, San Francisco | Completed | No outcome recorded |
| Phase 4 | NCT03389893 | Jul 2018 → Apr 2020 | atopic eczema | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | Met primary Stop: Enrollment |
| Phase not applicable3 trials | ||||||
| — | NCT06743581 | Feb 2025 → Feb 2027 expected | non-small cell lung carcinoma | University of Montreal Hospital Centre (CHUM) | Not yet recruiting | No outcome recorded |
| — | NCT06501807 | Jul 2024 → Sep 2034 expected | chronic rhinosinusitis, nasal cavity polyp | University Hospital, Lille | Recruiting | No outcome recorded |
| — | NCT03983460 | Mar 2020 → Jun 2021 | atopic eczema | Association pour la Recherche Clinique et Immunologique | Unknown | No outcome recorded |
| Phase not stated3 trials | ||||||
| — | NCT05906706 | — | bullous pemphigoid | Regeneron Pharmaceuticals | Approved for marketing | No outcome recorded |
| — | NCT03020810 | — | asthma | Sally E. Wenzel MD | Approved for marketing | No outcome recorded |
| — | NCT06631677 | — | food allergy | Regeneron Pharmaceuticals | Available | No outcome recorded |
| Comparator or background therapy38 trials | ||||||
| Phase 0 | NCT07358234 Comparator | Feb 2026 → Dec 2027 expected | eosinophilic esophagitis | Mayo Clinic | Enrolling by invitation | No outcome recorded |
| Phase 1 | NCT07334496 Comparator | Mar → Jul 2026 overdue | — | Gan & Lee Pharmaceuticals. | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07411755 Comparator | Mar → Sep 2026 overdue | atopic eczema | Jiangsu Genscend Biopharmaceutical Co., Ltd | Recruiting | No outcome recorded |
| Phase 1 | NCT07358156 Comparator | Feb → Nov 2026 expected | atopic eczema | Chong Kun Dang Pharmaceutical | Recruiting | No outcome recorded |
| Phase 1 | NCT07027527 Comparator | Jun 2025 → Aug 2026 overdue | atopic eczema | Apogee Therapeutics, Inc. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT06614907 Comparator | Aug → Nov 2024 | atopic eczema | Qilu Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT06369467 Background | May 2024 → Aug 2027 expected | food allergy | Regeneron Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 1 | NCT06193434 Comparator | Jan 2024 → Aug 2025 | atopic eczema | Innovent Biologics (Suzhou) Co. Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT07399067 Comparator | Feb 2026 → Mar 2027 expected | atopic eczema | Innovent Biologics (Suzhou) Co. Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT06881251 Comparator | Feb 2025 → Mar 2026 | atopic eczema | Janssen Research & Development, LLC | Terminated | No outcome recorded |
| Phase 2 | NCT06705387 Comparator | Dec 2024 → Sep 2026 overdue | eosinophilic esophagitis | University of Colorado, Denver | Recruiting | No outcome recorded |
| Phase 2 | NCT06226610 Comparator | Nov 2024 → Jan 2026 overdue | — | Akron Children's Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05470114 Comparator | May 2022 → Jun 2023 | atopic eczema | LEO Pharma | Completed | No outcome recorded |
| Phase 2 | NCT03678545 Comparator | May 2021 → Mar 2024 | eosinophilic gastritis | Children's Hospital Medical Center, Cincinnati | Completed | No outcome recorded |
| Phase 2 | NCT04791319 Comparator | May 2021 → Feb 2022 | atopic eczema | Janssen Research & Development, LLC | Terminated | Missed primary |
| Phase 2 | NCT04430179 Comparator | Dec 2020 → Jul 2025 overdue | chronic rhinosinusitis | University of South Florida | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04512339 Comparator | Aug 2020 → Aug 2022 | hand dermatosis | University Medical Center Groningen | Unknown | No outcome recorded |
| Phase 2 | NCT03749148 Comparator | Dec 2018 → Feb 2023 | cholinergic urticaria | Charite University, Berlin, Germany | Completed | No outcome recorded |
| Phase 2 | NCT03749135 Comparator | Nov 2018 → Jul 2021 | angioedema, chronic idiopathic urticaria | Charite University, Berlin, Germany | Completed | No outcome recorded |
| Phase 3 | NCT07783425 Comparator | Aug 2026 → Sep 2028 expected | atopic eczema | Pfizer | Recruiting | No outcome recorded |
| Phase 3 | NCT07386743 Comparator | Feb 2026 → Apr 2027 expected | atopic eczema | Jiangsu Genscend Biopharmaceutical Co., Ltd | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06868212 Comparator | Jul 2025 → Feb 2027 expected | chronic idiopathic urticaria | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT06884891 Comparator | Apr 2025 → May 2027 expected | atopic eczema | Qilu Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT03884842 Comparator | Jul 2019 → Oct 2022 | asthma | McMaster University | Completed | No outcome recorded |
| Phase 3 | NCT03720470 Comparator | Oct 2018 → Dec 2019 | atopic eczema | Pfizer | Completed | Met primary |
| Phase 4 | NCT06824649 Comparator | Jun 2026 → Feb 2030 expected | chronic rhinosinusitis, nasal cavity polyp | Medical University of South Carolina | Recruiting | No outcome recorded |
| Phase 4 | NCT07187583 Comparator | Jun 2025 → Mar 2028 expected | chronic rhinosinusitis | Rigshospitalet, Denmark | Recruiting | No outcome recorded |
| Phase 4 | NCT07268313 Comparator | Apr 2025 → Jun 2027 expected | nasal cavity polyp | Rigshospitalet, Denmark | Recruiting | No outcome recorded |
| Phase 4 | NCT06465732 Background | Jan → Nov 2025 overdue | atopic eczema | Second Affiliated Hospital, School of Medicine, Zhejiang University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06556264 Comparator | Aug 2024 → Jan 2025 overdue | asthma, chronic rhinosinusitis | Dr. Andrew Thamboo, MD | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06385236 Comparator | Feb 2024 → Jun 2027 expected | asthma | University of California, San Diego | Recruiting | No outcome recorded |
| Phase 4 | NCT05942222 Comparator | Apr 2023 → Apr 2026 overdue | asthma, chronic rhinosinusitis, eosinophil disorder | Rigshospitalet, Denmark | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04743791 Comparator | Oct 2022 → Jul 2026 overdue | asthma | Sally E. Wenzel MD | Recruiting | No outcome recorded |
| Phase 4 | NCT04380038 Comparator | May 2022 → Jun 2026 overdue | asthma | University of Virginia | Recruiting | No outcome recorded |
| — | NCT05834413 Background | May 2023 → Jun 2027 expected | lung cancer | Shanghai University of Traditional Chinese Medicine | Recruiting | No outcome recorded |
| — | NCT06509243 Comparator | Feb 2023 → Mar 2024 | atopic eczema | Medical University of Silesia | Completed | No outcome recorded |
| — | NCT04878770 Comparator | Aug 2021 → Jan 2024 | atopic eczema | Erasmus Medical Center | Unknown | No outcome recorded |
| — | NCT04776694 Background | — | — | Regeneron Pharmaceuticals | Available | No outcome recorded |
News releases announcing trial results or a regulatory action · 239
| Date | Issuer | Release |
|---|---|---|
| 2026-05-05 | Regeneron Pharmaceuticals | Results Dupixent® (dupilumab) Demonstrates Improved Esophageal Function in Eosinophilic Esophagitis (EoE) Phase 4 Trial regeneron.com ↗
Dupixent showed significant and clinically meaningful improvements in both esophageal distensibility as well as disease-related structural changes and inflammation in the esophagus in adult patients with EoE at week 24 compared to placebo, in results presented at DDW |
| 2026-04-22 | Sanofi | Regulatory Press Release: Sanofi and Regeneron’s Dupixent approved in the US as the first biologic medicine for young children with uncontrolled chronic spontaneous urticaria sanofi.com ↗
The US Food and Drug Administration has approved Dupixent (dupilumab) for the treatment of children aged two to 11 years with chronic spontaneous urticaria (CSU) who remain symptomatic despite histamine-1 antihistamine (H1AH) treatment. |
| 2026-04-22 | Regeneron Pharmaceuticals | Regulatory Dupixent® (dupilumab) Approved in the U.S. as the First Biologic Medicine for Young Children with Uncontrolled Chronic Spontaneous Urticaria (CSU) regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for the treatment of children aged 2 to 11 years with chronic spontaneous urticaria (CSU) who remain symptomatic despite histamine-1 antihistamine (H1AH) treatment. |
| 2026-04-13 | Sanofi | Regulatory Press Release: Sanofi and Regeneron’s Dupixent approved in the EU as the first targeted medicine to treat young children with chronic spontaneous urticaria sanofi.com ↗
Sanofi and Regeneron’s Dupixent approved in the EU as the first targeted medicine to treat young children with chronic spontaneous urticaria |
| 2026-04-13 | Regeneron Pharmaceuticals | Regulatory Dupixent® (dupilumab) Approved in the EU as the First Targeted Medicine to Treat Young Children with Chronic Spontaneous Urticaria (CSU) regeneron.com ↗
This expands the previous approval in the EU for adults and adolescents aged 12 years and older with CSU, a chronic, inflammatory skin disease that causes sudden and debilitating hives and recurring itch. |
| 2026-03-24 | Sanofi | Regulatory Press Release: Sanofi and Regeneron’s Dupixent approved in Japan as the first targeted medicine to treat adults with bullous pemphigoid sanofi.com ↗
The Ministry of Health, Labour and Welfare in Japan has granted marketing and manufacturing authorization for Dupixent (dupilumab) for the treatment of adults with moderate-to-severe bullous pemphigoid (BP). |
| 2026-03-24 | Regeneron Pharmaceuticals | Regulatory Dupixent® (dupilumab) Approved in Japan as the First Targeted Medicine to Treat Adults with Bullous Pemphigoid (BP) regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the Ministry of Health, Labour and Welfare (MHLW) in Japan has approved Dupixent® (dupilumab) for the treatment of adults with moderate-to-severe bullous pemphigoid (BP). |
| 2026-02-27 | Sanofi | Regulatory Press Release: Sanofi and Regeneron’s Dupixent recommended for EU approval to treat chronic spontaneous urticaria in young children with ongoing symptoms despite treatment sanofi.com ↗
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of Dupixent (dupilumab) in the EU for the treatment of chronic spontaneous urticaria (CSU). |
| 2026-02-27 | Regeneron Pharmaceuticals | Regulatory Dupixent® (dupilumab) Recommended for EU Approval to Treat Chronic Spontaneous Urticaria (CSU) in Young Children with Ongoing Symptoms Despite Treatment regeneron.com ↗
This recommendation covers children aged 2 to 11 years with moderate-to-severe CSU, an inadequate response to histamine-1 antihistamines (H1AH) and who are naïve to anti-immunoglobulin E (IgE) therapy for CSU. |
| 2026-02-24 | Sanofi | Regulatory Press Release: Sanofi and Regeneron’s Dupixent approved in the US as the first and only medicine for allergic fungal rhinosinusitis sanofi.com ↗
The US Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for the treatment of adult and pediatric patients aged 6 years and older with allergic fungal rhinosinusitis (AFRS) who have a history of sino-nasal surgery. |
| 2026-02-24 | Regeneron Pharmaceuticals | Regulatory Dupixent® (dupilumab) Approved in the U.S. as the First and Only Medicine for Allergic Fungal Rhinosinusitis (AFRS) regeneron.com ↗
This approval expands our approved indications in sino-nasal diseases to now include AFRS, alongside chronic rhinosinusitis with nasal polyps. |
| 2026-02-10 | Regeneron Pharmaceuticals | Results Regeneron Highlights Expanding Immunology Portfolio and Pipeline at AAAAI, Showcasing Novel Approaches to Treating Allergy regeneron.com ↗
Dupilumab With Medium-Dose Inhaled Corticosteroids Versus Omalizumab With High-Dose Inhaled Corticosteroids Improves Clinical Outcomes In Patients With Coexisting Chronic Rhinosinusitis With Nasal Polyps And Uncontrolled Asthma |
| 2025-12-23 | Sanofi | Regulatory Press Release: Sanofi and Regeneron’s Dupixent approved in Japan for children aged 6 to 11 years with bronchial asthma sanofi.com ↗
The Ministry of Health, Labour and Welfare in Japan has granted marketing and manufacturing authorization for Dupixent (dupilumab) for the treatment of bronchial asthma in children aged 6 to 11 years with severe or refractory disease whose symptoms are inadequately controlled with existing therapy. |
| 2025-12-23 | Regeneron Pharmaceuticals | Regulatory Dupixent® (dupilumab) Approved in Japan for Children Aged 6 to 11 Years with Bronchial Asthma regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the Ministry of Health, Labour and Welfare (MHLW) in Japan has granted marketing and manufacturing authorization for Dupixent® (dupilumab) for the treatment of bronchial asthma in children aged 6 to 11 years with severe or refractory disease whose symptoms are inadequately controlled with existing therapy. |
| 2025-11-25 | Sanofi | Regulatory Press Release: Sanofi and Regeneron’s Dupixent approved as the first targeted medicine in the EU in over a decade for chronic spontaneous urticaria sanofi.com ↗
Sanofi and Regeneron’s Dupixent approved as the first targeted medicine in the EU in over a decade for chronic spontaneous urticaria |
| 2025-11-25 | Regeneron Pharmaceuticals | Regulatory Dupixent® (dupilumab) Approved as the First Targeted Medicine in the European Union (EU) in Over a Decade for Chronic Spontaneous Urticaria (CSU) regeneron.com ↗ |
| 2025-11-07 | Sanofi | Results Press Release: ACAAI: Sanofi and Regeneron’s Dupixent pivotal study met all primary and secondary endpoints, reducing signs and symptoms of allergic fungal rhinosinusitis; sBLA accepted for FDA priority review sanofi.com ↗
Positive results from the pivotal LIBERTY-AFRS-AIMS phase 3 study ( NCT04684524 ) evaluating the investigational use of Dupixent (dupilumab) in adults and children aged 6 years and older with allergic fungal rhinosinusitis (AFRS) demonstrated significant improvements in signs and symptoms of disease across all primary and secondary endpoints, including reductions in sinus opacification, nasal congestion, and nasal polyps compared to placebo. |
| 2025-11-07 | Regeneron Pharmaceuticals | Results Dupixent® (dupilumab) Pivotal Trial Met All Primary and Secondary Endpoints, Reducing Signs and Symptoms of Allergic Fungal Rhinosinusitis (AFRS); sBLA Accepted for FDA Priority Review regeneron.com ↗
The trial demonstrated significant improvements in signs and symptoms of disease across all primary and secondary endpoints, including reductions in sinus opacification, nasal congestion and nasal polyps compared to placebo. |
| 2025-09-22 | Sanofi | Regulatory Press Release: Sanofi and Regeneron’s Dupixent to treat chronic spontaneous urticaria advances in EU with positive CHMP opinion sanofi.com ↗
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Dupixent (dupilumab) in the EU for the treatment of chronic spontaneous urticaria (CSU) in adults and adolescents. |
| 2025-09-22 | Regeneron Pharmaceuticals | Regulatory Dupixent® (dupilumab) to Treat Chronic Spontaneous Urticaria (CSU) Advances in EU with Positive CHMP Opinion regeneron.com ↗ |
| 2025-09-04 | Sanofi | Results Media Update: ERS: new data across Sanofi’s immunology pipeline reinforce leadership in respiratory diseases sanofi.com ↗
Dupilumab Reduces the Risk of Severe Exacerbations in Patients with Chronic Obstructive Pulmonary Disease: Results from BOREAS and NOTUS |
| 2025-09-03 | Sanofi | Results Media Update: EADV: Sanofi builds on legacy in immunology with new data highlighting advances in treatment of chronic inflammatory skin diseases sanofi.com ↗
The safety results of these studies were generally consistent with the known safety profile of Dupixent in its approved dermatological indications. |
| 2025-08-19 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - DUPILUMAB INJECTION OBTAINS CLINICAL TRIAL APPROVAL IN CHINA irasia.com ↗
DUPILUMAB INJECTION OBTAINS CLINICAL TRIAL APPROVAL IN CHI NA |
| 2025-06-20 | Sanofi | Regulatory Press Release: Dupixent approved in the US as the only targeted medicine to treat patients with bullous pemphigoid sanofi.com ↗
The US Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for the treatment of adult patients with bullous pemphigoid (BP). |
| 2025-06-20 | Regeneron Pharmaceuticals | Regulatory Dupixent® (dupilumab) Approved in the U.S. as the Only Targeted Medicine to Treat Patients with Bullous Pemphigoid (BP) regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for the treatment of adult patients with bullous pemphigoid (BP). |
| 2025-06-15 | Sanofi | Results Press Release: EAACI: Dupixent demonstrated superiority over Xolair (omalizumab) in chronic rhinosinusitis with nasal polyps in patients with coexisting asthma in first-ever presented phase 4 head-to-head respiratory study sanofi.com ↗
In the study, Dupixent (dupilumab) outperformed Xolair (omalizumab) on all primary and secondary efficacy endpoints of CRSwNP, and in all asthma-related endpoints. |
| 2025-06-15 | Regeneron Pharmaceuticals | Results Dupixent® (dupilumab) Demonstrated Superiority Over Xolair® (Omalizumab) in Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) in Patients with Coexisting Asthma in First-ever Presented Phase 4 Head-to-Head Respiratory Trial regeneron.com ↗
In the trial, Dupixent® (dupilumab) outperformed Xolair® (omalizumab) on all primary and secondary efficacy endpoints of CRSwNP, and in all asthma-related endpoints. |
| 2025-06-07 | Sanofi | Results Media Update: RAD: Dupixent data reinforce use in atopic dermatitis patients with skin of color sanofi.com ↗
These are the first clinical study results for Dupixent in a large population of patients with darker skin tones. |
| 2025-06-07 | Regeneron Pharmaceuticals | Results Dupixent® (dupilumab) Data at Revolutionizing Atopic Dermatitis (RAD) Conference Reinforce Use in Atopic Dermatitis Patients with Skin of Color regeneron.com ↗
Dupixent achieved 75% or greater improvement in overall disease severity, the primary endpoint, in more than three-quarters of treated patients |
| 2025-04-18 | Sanofi | Regulatory Press Release: Dupixent approved in the US as the first new targeted therapy in over a decade for chronic spontaneous urticaria sanofi.com ↗
The US Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for the treatment of adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite histamine-1 (H1) antihistamine treatment. |
| 2025-04-18 | Regeneron Pharmaceuticals | Regulatory Dupixent® (dupilumab) Approved in the U.S. as the First New Targeted Therapy in Over a Decade for Chronic Spontaneous Urticaria (CSU) regeneron.com ↗ |
| 2025-03-28 | Sanofi | Regulatory Press Release: Dupixent approved as the first-ever biologic medicine in Japan for patients with COPD sanofi.com ↗
The Ministry of Health, Labour and Welfare in Japan has granted marketing and manufacturing authorization for Dupixent (dupilumab) for the treatment of chronic obstructive pulmonary disease (COPD) in adults whose disease is not adequately controlled with existing therapy. |
| 2025-03-28 | Regeneron Pharmaceuticals | Regulatory Dupixent® (dupilumab) Approved as the First-ever Biologic Medicine in Japan for Patients with Chronic Obstructive Pulmonary Disease (COPD) regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the Ministry of Health, Labour and Welfare (MHLW) in Japan has granted marketing and manufacturing authorization for Dupixent® (dupilumab) for the treatment of chronic obstructive pulmonary disease (COPD) in adults whose disease is not adequately controlled with existing therapy. |
| 2025-03-08 | Sanofi | Results Press Release: Dupixent late-breaking positive pivotal data in bullous pemphigoid presented at AAD sanofi.com ↗
Positive results from the pivotal ADEPT phase 2/3 study evaluating the investigational use of Dupixent (dupilumab) in adults with moderate-to-severe bullous pemphigoid (BP) were shared in a late-breaking oral presentation at the 2025 American Academy of Dermatology (AAD) Annual Meeting. |
| 2025-03-08 | Regeneron Pharmaceuticals | Results Dupixent® (dupilumab) Late-Breaking Positive Pivotal Data in Bullous Pemphigoid Presented at AAD regeneron.com ↗
Five times more adults on Dupixent achieved sustained disease remission at 36 weeks compared to placebo; significant reductions were also seen in disease severity and itch |
| 2025-02-28 | Sanofi | Results Media Update: AAD: new data advance Sanofi’s scientific leadership across innovative treatments for inflammatory skin diseases sanofi.com ↗
Positive Dupixent data include a late-breaking oral presentation featuring phase 2/3 data evaluating the efficacy and safety of Dupixent in patients with BP |
| 2025-02-18 | Sanofi | Regulatory Press Release: Dupixent sBLA accepted for FDA priority review for the targeted treatment of bullous pemphigoid sanofi.com ↗
The US Food and Drug Administration (FDA) has accepted for priority review the supplemental biologics license application (sBLA) for Dupixent (dupilumab) to treat adults with bullous pemphigoid (BP). |
| 2025-02-18 | Regeneron Pharmaceuticals | Regulatory Dupixent® (dupilumab) sBLA Accepted for FDA Priority Review for the Targeted Treatment of Bullous Pemphigoid (BP) regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) to treat adults with bullous pemphigoid (BP). |
| 2025-01-13 | Regeneron Pharmaceuticals | Results Regeneron Provides Business Updates and Highlights from Broad Clinical Pipeline at the 43rd Annual J.P. Morgan Healthcare Conference regeneron.com ↗
A trial in patients with severe food allergies is ongoing, with initial clinical data shared in today’s presentation showing profound reduction of IgE in the first patient treated with this two-drug approach. |
| 2024-11-15 | Sanofi | Regulatory Press Release: Dupixent sBLA accepted for FDA review for the treatment of chronic spontaneous urticaria sanofi.com ↗
The US Food and Drug Administration (FDA) has accepted for review the resubmission of the supplemental biologics license application (sBLA) for Dupixent (dupilumab) to treat adults and pediatric patients aged 12 years and older with chronic spontaneous urticaria (CSU) whose disease is not adequately controlled with H1 antihistamine treatment. |
| 2024-11-15 | Regeneron Pharmaceuticals | Regulatory Dupixent® (dupilumab) sBLA Accepted for FDA Review for the Treatment of Chronic Spontaneous Urticaria (CSU) regeneron.com ↗ |
| 2024-11-06 | Sanofi | Regulatory Press Release: Dupixent approved in the EU as the first and only medicine for young children with eosinophilic esophagitis sanofi.com ↗
The European Medicines Agency has approved Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) in children as young as one year of age. |
| 2024-11-06 | Regeneron Pharmaceuticals | Regulatory Dupixent® (dupilumab) Approved in the European Union as the First and Only Medicine for Young Children with Eosinophilic Esophagitis regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Commission (EC) has approved Dupixent® (dupilumab) to treat eosinophilic esophagitis (EoE) in children as young as 1 year of age. |
| 2024-10-24 | Sanofi | Results Press Release: Dupixent late-breaking positive phase 3 data in chronic spontaneous urticaria to be presented at ACAAI sanofi.com ↗
Results showed treatment with Dupixent significantly reduced itch and urticaria activity (itch and hive) scores from baseline, and a higher proportion of patients achieved well-controlled disease status, compared to placebo. |
| 2024-10-24 | Regeneron Pharmaceuticals | Results Dupixent® (dupilumab) Late-Breaking Positive Phase 3 Data in Chronic Spontaneous Urticaria to Be Presented at ACAAI regeneron.com ↗
Results showed treatment with Dupixent significantly reduced itch and urticaria activity (itch and hive) scores from baseline, and a higher proportion of patients achieved well-controlled disease status compared to placebo. |
| 2024-09-27 | Sanofi | Regulatory Press Release: Dupixent approved in the US as the first-ever biologic medicine for patients with COPD sanofi.com ↗
The US Food and Drug Administration (FDA) has approved Dupixent (dupilumab) as an add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. |
| 2024-09-27 | Sanofi | Regulatory Press Release: Dupixent approved in China as the first-ever biologic medicine for patients with COPD sanofi.com ↗
The National Medical Products Administration (NMPA) in China has approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils. |
| 2024-09-27 | Regeneron Pharmaceuticals | Regulatory Dupixent® (dupilumab) Approved in the U.S. as the First-ever Biologic Medicine for Patients with COPD regeneron.com ↗
Dupixent is the first biologic medicine approved in the U.S. to treat these patients. |
| 2024-09-27 | Regeneron Pharmaceuticals | Regulatory Dupixent® (dupilumab) Approved in China as the First-ever Biologic Medicine for Patients with Chronic Obstructive Pulmonary Disease (COPD) regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the National Medical Products Administration (NMPA) in China has approved Dupixent® (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils. |
| 2024-09-25 | Sanofi | Results Media Update: EADV: New data reinforce Sanofi’s innovative approach and leadership across immune-mediated skin diseases sanofi.com ↗
New data show impact of Dupixent on potential for clinical remission in children as young as six years of age with moderate-to-severe AD |
| 2024-09-20 | Sanofi | Regulatory Press Release: Dupixent recommended for EU approval by the CHMP to treat eosinophilic esophagitis in children as young as 1 year old sanofi.com ↗
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the expanded approval of Dupixent (dupilumab) in the European Union (EU) for eosinophilic esophagitis (EoE) in children down to 1 year of age. |
| 2024-09-20 | Regeneron Pharmaceuticals | Regulatory Dupixent® (dupilumab) Recommended for EU Approval by the CHMP to Treat Eosinophilic Esophagitis (EoE) in Children as Young as 1 Year Old regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the expanded approval of Dupixent® (dupilumab) in the European Union (EU) for eosinophilic esophagitis (EoE) in children down to 1 year of age. |
| 2024-09-13 | Regeneron Pharmaceuticals | Regulatory Dupixent® (dupilumab) Approved in the U.S. as First and Only Treatment for Adolescents with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) as an add-on maintenance treatment for adolescent patients aged 12 to 17 years with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). |
| 2024-09-11 | Sanofi | Results Press Release: Dupixent phase 3 study confirms significant improvements in itch and hives for patients with CSU sanofi.com ↗
A Dupixent (dupilumab) confirmatory phase 3 study (LIBERTY-CUPID Study C) met the primary and key secondary endpoints for the investigational treatment of patients with uncontrolled, biologic-naïve CSU receiving background therapy with antihistamines. |
| 2024-09-11 | Sanofi | Results Press Release: Dupixent is the first and only biologic to achieve significant improvements in disease remission and symptoms in bullous pemphigoid positive pivotal study sanofi.com ↗
A Dupixent (dupilumab) pivotal study (ADEPT) in bullous pemphigoid (BP) met the primary and all key secondary endpoints evaluating its investigational use in adults with moderate-to-severe disease. |
| 2024-09-11 | Regeneron Pharmaceuticals | Results Dupixent® (dupilumab) Phase 3 Trial Confirms Significant Improvements in Itch and Hives for Patients with Chronic Spontaneous Urticaria (CSU) regeneron.com ↗ |
| 2024-09-11 | Regeneron Pharmaceuticals | Results Dupixent® (dupilumab) Is the First and Only Biologic to Achieve Significant Improvements in Disease Remission and Symptoms in Bullous Pemphigoid (BP) Positive Pivotal Trial regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that a Dupixent® (dupilumab) pivotal trial (ADEPT) in bullous pemphigoid (BP) met the primary and all key secondary endpoints evaluating its investigational use in adults with moderate-to-severe disease. |
| 2024-09-10 | Sanofi | Results Media Update: ERS: Dupixent data reinforce clinically meaningful benefit from pooled analysis of two COPD phase 3 studies sanofi.com ↗
Dupixent patients (n=938) achieved the following compared to placebo (n=936): 31% reduction in the annualized rate of moderate or severe COPD exacerbations over 52 weeks (nominal p<0.0001). |
| 2024-08-26 | Regeneron Pharmaceuticals | Results Latest Dupixent® (dupilumab) and Itepekimab Data at ERS Highlight Scientific Innovation and Leadership in Respiratory Diseases regeneron.com ↗
Data from landmark Phase 3 trials for Dupixent in COPD reinforce exacerbation reduction and improvement in lung function compared to placebo, and provide new assessments on health-related quality of life across patient subgroups |
| 2024-07-03 | Sanofi | Regulatory Press Release: Dupixent approved in the EU as the first-ever targeted therapy for patients with COPD sanofi.com ↗
The European Medicines Agency (EMA) has approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils. |
| 2024-07-03 | Regeneron Pharmaceuticals | Regulatory Dupixent® (dupilumab) Approved in the European Union as the First-ever Targeted Therapy for Patients with COPD regeneron.com ↗
The EC is the first regulatory authority in the world to approve Dupixent for COPD patients. |
| 2024-06-26 | Sanofi | Results Press Release: Dupixent positive phase 3 data in children one to 11 years of age with eosinophilic esophagitis published in NEJM sanofi.com ↗
The New England Journal of Medicine has published results from a positive phase 3 study of Dupixent (dupilumab) in children aged one to 11 years with eosinophilic esophagitis (EoE). |
| 2024-06-26 | Regeneron Pharmaceuticals | Results Dupixent® (dupilumab) Positive Phase 3 Data in Children 1 to 11 Years of Age with Eosinophilic Esophagitis Published in the New England Journal of Medicine regeneron.com ↗
The trial showed a greater proportion of those receiving weight-tiered higher dose Dupixent experienced significant improvements in many key disease measures of EoE, compared to placebo at week 16. |
| 2024-05-31 | Sanofi | Regulatory Press Release: Dupixent recommended for EU approval by the CHMP to treat patients with COPD sanofi.com ↗
Dupixent recommended for EU approval by the CHMP to treat patients with COPD |
| 2024-05-31 | Sanofi | Regulatory Press Release: Update on FDA priority review of Dupixent for the treatment of COPD patients with type 2 inflammation sanofi.com ↗
The US Food and Drug Administration (FDA) has extended by three months the target action date of its priority review of the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD). |
| 2024-05-31 | Regeneron Pharmaceuticals | Regulatory Update on FDA Priority Review of Dupixent® (dupilumab) for the Treatment of COPD Patients with Type 2 Inflammation regeneron.com ↗ |
| 2024-05-31 | Regeneron Pharmaceuticals | Regulatory Dupixent® (dupilumab) Recommended for EU Approval by the CHMP to Treat Patients with COPD regeneron.com ↗ |
| 2024-05-20 | Sanofi | Results Press Release: Dupixent® late-breaking data from NOTUS confirmatory phase 3 COPD study presented at ATS and published in NEJM sanofi.com ↗
NOTUS results confirm landmark data from the phase 3 BOREAS study and show Dupixent significantly reduced exacerbations by 34% and improved lung function, compared to placebo, in uncontrolled chronic obstructive pulmonary disease (COPD) with evidence of type 2 inflammation |
| 2024-05-20 | Regeneron Pharmaceuticals | Results Dupixent® (dupilumab) Late-Breaking Data from NOTUS Confirmatory Phase 3 COPD Trial Presented at ATS and Published in The New England Journal of Medicine regeneron.com ↗
NOTUS results confirm landmark data from the Phase 3 BOREAS trial and show Dupixent significantly reduced exacerbations by 34% and improved lung function, compared to placebo, in uncontrolled chronic obstructive pulmonary disease (COPD) with evidence of type 2 inflammation |
| 2024-05-13 | Regeneron Pharmaceuticals | Regulatory Dupixent® (dupilumab) sBLA Accepted for FDA Priority Review for Treatment of Adolescents with Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP) regeneron.com ↗ |
| 2024-04-26 | Sanofi | Results Media Update: New data presented at ATS demonstrate Sanofi’s leadership in advancing potential new therapies for patients with immune-mediated respiratory diseases sanofi.com ↗
Late-breaking data from the landmark NOTUS and BOREAS phase 3 studies support Dupixent’s role as a potential first-in-class biologic treatment for certain adult patients with uncontrolled COPD with type 2 inflammation |
| 2024-04-25 | AbbVie | Results New Data Show RINVOQ® (upadacitinib) Demonstrated Superiority Versus DUPIXENT® (dupilumab) Across Primary and All Secondary Endpoints in an Open-Label Head-to-Head Atopic Dermatitis Study abbvie.com ↗
Upadacitinib demonstrated superiority versus dupilumab in primary endpoint of simultaneous achievement of near complete skin clearance (EASI 90) and no to little itch (WP-NRS 0/1) at Week 16 |
| 2024-02-24 | Sanofi | Results Media Update: Dupixent® continues scientific leadership with late-breaking results showing reduced airway inflammation and mucus plugging in adults with uncontrolled moderate-to-severe asthma sanofi.com ↗ |
| 2024-02-23 | Sanofi | Regulatory Press Release: Dupixent® sBLA accepted for FDA Priority Review for treatment of COPD with type 2 inflammation sanofi.com ↗
The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent ® (dupilumab) in a sixth potential indication as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD). |
| 2024-02-23 | Regeneron Pharmaceuticals | Regulatory Dupixent® (dupilumab) sBLA Accepted for FDA Priority Review for Treatment of COPD with Type 2 Inflammation regeneron.com ↗ |
| 2024-02-16 | Sanofi | Regulatory Press Release: Japan first in the world to approve Dupixent® for chronic spontaneous urticaria (CSU) sanofi.com ↗
Japan is the first country to approve Dupixent for CSU, emphasizing the value of Dupixent as a novel treatment option to manage this disease in patients with unmet needs. |
| 2024-02-16 | Regeneron Pharmaceuticals | Regulatory Japan First in the World to Approve Dupixent® (dupilumab) for Chronic Spontaneous Urticaria (CSU) regeneron.com ↗
Japan is the first country to approve Dupixent for CSU, emphasizing the value of Dupixent as a novel treatment option to manage this disease in patients with unmet needs. |
| 2024-01-25 | Sanofi | Regulatory Press Release: Dupixent® FDA approved as first and only treatment indicated for children aged 1 year and older with eosinophilic esophagitis (EoE) sanofi.com ↗
The U.S. Food and Drug Administration (FDA) has approved Dupixent ® (dupilumab) for the treatment of pediatric patients aged 1 to 11 years, weighing at least 15 kg, with eosinophilic esophagitis (EoE). |
| 2024-01-25 | Regeneron Pharmaceuticals | Regulatory Dupixent® (dupilumab) FDA Approved as First and Only Treatment Indicated for Children Aged 1 Year and Older with Eosinophilic Esophagitis (EoE) regeneron.com ↗
Dupixent is now the first and only medicine approved in the U.S. specifically indicated to treat these patients. |
| 2024-01-16 | Sanofi | Regulatory Press Release: Dupixent® (dupilumab) U.S. label updated with data further supporting use in atopic dermatitis with moderate-to-severe hand and foot involvement sanofi.com ↗
The U.S. Food and Drug Administration (FDA) has updated the label for Dupixent ® (dupilumab) in atopic dermatitis, adding efficacy and safety data for patients aged 12 years and older with atopic dermatitis with uncontrolled moderate-to-severe hand and/or foot involvement. |
| 2024-01-16 | Regeneron Pharmaceuticals | Regulatory Dupixent® (dupilumab) U.S. Label Updated with Data Further Supporting Use in Atopic Dermatitis with Moderate-to-Severe Hand and Foot Involvement regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has updated the label for Dupixent® (dupilumab) in atopic dermatitis, adding efficacy and safety data for patients aged 12 years and older with atopic dermatitis with uncontrolled moderate-to-severe hand and/or foot involvement. |
| 2023-11-27 | Sanofi | Results Press Release: Dupixent® significantly reduced COPD exacerbations in second positive Phase 3 trial, accelerating FDA submission and confirming potential to become first approved biologic for this serious disease sanofi.com ↗
The second Dupixent ® (dupilumab) investigational Phase 3 chronic obstructive pulmonary disease (COPD) trial (NOTUS) has shown that Dupixent significantly reduced (34%) exacerbations, confirming positive published results from the landmark Phase 3 BOREAS trial. |
| 2023-11-27 | Regeneron Pharmaceuticals | Results Dupixent® (dupilumab) Significantly Reduced COPD Exacerbations in Second Positive Phase 3 Trial, Accelerating FDA Submission and Confirming Potential to Become First Approved Biologic for This Serious Disease regeneron.com ↗
The NOTUS trial also confirmed that treatment with Dupixent led to rapid and significant improvements in lung function by 12 weeks and were sustained at 52 weeks. |
| 2023-10-22 | Sanofi | Results Press Release: Dupixent® (dupilumab) Phase 3 Results show sustained efficacy for up to one year in children 1 to 11 years of age with eosinophilic esophagitis (EoE) sanofi.com ↗
Positive results from a Phase 3 trial demonstrated the efficacy and safety profile of Dupixent ® (dupilumab) for up to one year (52 weeks) in children aged 1 to 11 years with eosinophilic esophagitis (EoE) was consistent. |
| 2023-10-22 | Regeneron Pharmaceuticals | Results Dupixent® (dupilumab) Phase 3 Results Show Sustained Efficacy for Up to One Year in Children 1 to 11 Years of Age with Eosinophilic Esophagitis (EoE) regeneron.com ↗
Late-breaking presentation at ACG 2023 showed histologic and endoscopic improvements were maintained with no new safety signals to week 52 with higher dose Dupixent in these children |
| 2023-10-20 | Sanofi | Regulatory Press Release: Sanofi and Regeneron provide update on Dupixent® (dupilumab) sBLA for Chronic Spontaneous Urticaria sanofi.com ↗
The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the supplemental Biologics License Application (sBLA) for Dupixent ® (dupilumab) in chronic spontaneous urticaria (CSU). |
| 2023-10-20 | Regeneron Pharmaceuticals | Regulatory Regeneron and Sanofi Provide Update on Dupixent® (dupilumab) sBLA for Chronic Spontaneous Urticaria regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) in chronic spontaneous urticaria (CSU). |
| 2023-09-26 | Sanofi | Regulatory Press Release: Dupixent® (dupilumab) sBLA for treatment of eosinophilic esophagitis in children aged 1 to 11 accepted for FDA Priority Review sanofi.com ↗
The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent ® (dupilumab) to treat children aged 1 to 11 years with eosinophilic esophagitis (EoE). |
| 2023-09-26 | Regeneron Pharmaceuticals | Regulatory Dupixent® (dupilumab) sBLA for Treatment of Eosinophilic Esophagitis (EoE) in Children Aged 1 to 11 Accepted for FDA Priority Review regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) to treat children aged 1 to 11 years with eosinophilic esophagitis (EoE). |
| 2023-09-05 | Sanofi | Results Media Update: New data at ERS showcases Sanofi's scientific leadership in addressing unmet needs across a variety of respiratory conditions sanofi.com ↗
Additionally, new data from a Phase 3 trial in children aged 6 to 11 years with moderate-to-severe asthma (VOYAGE) show Dupixent reduced systemic corticosteroid use related to exacerbations compared to placebo regardless of prior exacerbation history. |
| 2023-05-21 | Sanofi | Results Press Release: Dupixent® (dupilumab) late-breaking Phase 3 COPD results presented at ATS and simultaneously published in the New England Journal of Medicine sanofi.com ↗
Dupixent is the first and only investigational biologic for COPD that has demonstrated a significant reduction in moderate or severe acute exacerbations by 30% compared to placebo |
| 2023-05-21 | Regeneron Pharmaceuticals | Results Dupixent® (dupilumab) Late-breaking Phase 3 COPD Results Presented at ATS and Simultaneously Published in the New England Journal of Medicine regeneron.com ↗
Dupixent is the first and only investigational biologic for COPD that has demonstrated a significant reduction in moderate or severe acute exacerbations by 30% compared to placebo |
| 2023-05-08 | Sanofi | Results Media Update: Positive data from two Phase 3 Dupixent® (dupilumab) trials in prurigo nodularis published in Nature Medicine sanofi.com ↗
Positive results from two Phase 3 Dupixent ® (dupilumab) trials in adults with uncontrolled prurigo nodularis have been published in Nature Medicine. |
| 2023-03-23 | Sanofi | Results Press Release: Dupixent® demonstrates potential to become first biologic to treat COPD by showing significant reduction in exacerbations in pivotal trial sanofi.com ↗
The primary and all key secondary endpoints were met in a Phase 3 trial evaluating the investigational use of Dupixent ® (dupilumab) compared to placebo in adults currently on maximal standard-of-care inhaled therapy (triple therapy) with uncontrolled chronic obstructive pulmonary disease (COPD) and evidence of type 2 inflammation. |
| 2023-03-23 | Regeneron Pharmaceuticals | Results Dupixent® (dupilumab) Demonstrates Potential to Become First Biologic to Treat COPD by Showing Significant Reduction in Exacerbations in Pivotal Trial regeneron.com ↗ |
| 2023-03-21 | Sanofi | Regulatory Press Release: Dupixent® (dupilumab) approved by European Commission as first and only targeted medicine for children as young as six months old with severe atopic dermatitis sanofi.com ↗
The European Commission (EC) has approved Dupixent ® (dupilumab) in the European Union (EU) to treat severe atopic dermatitis in children aged 6 months to 5 years old who are candidates for systemic therapy. |
| 2023-03-21 | Regeneron Pharmaceuticals | Regulatory Dupixent® (dupilumab) Approved by European Commission as First and Only Targeted Medicine for Children as Young as Six Months Old with Severe Atopic Dermatitis regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Commission (EC) has approved Dupixent® (dupilumab) in the European Union (EU) to treat severe atopic dermatitis in children aged 6 months to 5 years old who are candidates for systemic therapy. |
| 2023-03-18 | Sanofi | Results Press Release: Dupixent® (dupilumab) late-breaking data at AAD show significant improvements in signs and symptoms of moderate-to-severe atopic hand and foot dermatitis sanofi.com ↗
Positive results from the clinical trial assessing Dupixent ® (dupilumab) in adults and adolescents with uncontrolled moderate-to-severe atopic hand and foot dermatitis were presented today. |
| 2023-03-18 | Regeneron Pharmaceuticals | Results Dupixent® (dupilumab) Late-Breaking Data at AAD Show Significant Improvements in Signs and Symptoms of Moderate-to-severe Atopic Hand and Foot Dermatitis regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today presented positive results from the clinical trial assessing Dupixent® (dupilumab) in adults and adolescents with uncontrolled moderate-to-severe atopic hand and foot dermatitis. |
| 2023-03-07 | Sanofi | Regulatory Press Release: Dupixent® (dupilumab) application for treatment of chronic spontaneous urticaria (CSU) in adults and adolescents accepted for FDA review sanofi.com ↗
Dupixent ® (dupilumab) application for treatment of chronic spontaneous urticaria (CSU) in adults and adolescents accepted for FDA review |
| 2023-03-07 | Regeneron Pharmaceuticals | Regulatory Dupixent® (dupilumab) Application for Treatment of Chronic Spontaneous Urticaria (CSU) in Adults and Adolescents Aged 12 Years and Older Accepted for FDA Review regeneron.com ↗ |
| 2023-01-30 | Sanofi | Regulatory Press Release: Dupixent® (dupilumab) approved by European Commission as the first and only targeted medicine indicated for eosinophilic esophagitis sanofi.com ↗
With this approval, Dupixent is the first and only targeted medicine specifically indicated to treat EoE in Europe and the U.S. |
| 2023-01-30 | Regeneron Pharmaceuticals | Regulatory Dupixent® (dupilumab) Approved by European Commission as the First and Only Targeted Medicine Indicated for Eosinophilic Esophagitis regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Commission (EC) expanded the marketing authorization for Dupixent® (dupilumab) in the European Union (EU) to treat eosinophilic esophagitis (EoE) in adults and adolescents 12 years and older, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy. |
| 2023-01-27 | Sanofi | Regulatory Press Release: Dupixent® (dupilumab) recommended for expanded EU approval by the CHMP to treat children as young as six months old with severe atopic dermatitis sanofi.com ↗
The European Commission is expected to announce a final decision on the Dupixent application in the coming months. |
| 2023-01-27 | Regeneron Pharmaceuticals | Regulatory Dupixent® (dupilumab) Recommended for Expanded EU Approval by the CHMP to Treat Children as Young as Six Months Old with Severe Atopic Dermatitis regeneron.com ↗ |
| 2022-12-21 | Sanofi | Results Press Release: Positive Dupixent® (dupilumab) Phase 3 results in adults and adolescents with eosinophilic esophagitis published in the New England Journal of Medicine sanofi.com ↗
Patients receiving Dupixent weekly experienced improvement in the ability to swallow and achieved histological disease remission. |
| 2022-12-21 | Regeneron Pharmaceuticals | Results Positive Dupixent® (dupilumab) Phase 3 Results in Adults and Adolescents with Eosinophilic Esophagitis Published in the New England Journal of Medicine regeneron.com ↗
Patients receiving Dupixent weekly experienced improvement in the ability to swallow and achieved histological disease remission. |
| 2022-12-16 | Sanofi | Regulatory Press Release: Dupixent® (dupilumab) recommended for EU approval by the CHMP for the treatment of eosinophilic esophagitis sanofi.com ↗
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the approval of Dupixent ® (dupilumab) in the European Union (EU) to treat adults and adolescents with eosinophilic esophagitis (EoE). |
| 2022-12-16 | Regeneron Pharmaceuticals | Regulatory Dupixent® (dupilumab) Recommended for EU Approval by the CHMP for the Treatment of Eosinophilic Esophagitis regeneron.com ↗
the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the approval of Dupixent® (dupilumab) in the European Union (EU) to treat adults and adolescents with eosinophilic esophagitis (EoE). |
| 2022-12-15 | Sanofi | Regulatory Press Release: Dupixent® (dupilumab) approved by European Commission as the first and only targeted medicine indicated for prurigo nodularis sanofi.com ↗
The European Commission (EC) has expanded the marketing authorization for Dupixent ® (dupilumab) in the European Union to treat adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy. |
| 2022-12-15 | Regeneron Pharmaceuticals | Regulatory Dupixent® (dupilumab) Approved by European Commission as the First and Only Targeted Medicine Indicated for Prurigo Nodularis regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Commission (EC) has expanded the marketing authorization for Dupixent® (dupilumab) in the European Union to treat adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy. |
| 2022-11-11 | Sanofi | Regulatory Press Release: Dupixent® (dupilumab) recommended for EU approval by the CHMP for the treatment of prurigo nodularis sanofi.com ↗ |
| 2022-11-11 | Regeneron Pharmaceuticals | Regulatory Dupixent® (dupilumab) Recommended for EU Approval by the CHMP for the Treatment of Prurigo Nodularis regeneron.com ↗ |
| 2022-10-11 | Sanofi | Results Press Release: Dupixent® (dupilumab) late-breaking Phase 3 data presented at UEG Week 2022 showed significant histological remission of eosinophilic esophagitis (EoE) in children 1 to 11 years old sanofi.com ↗
68% of children on a higher dose of Dupixent achieved histological disease remission at week 16 |
| 2022-10-11 | Regeneron Pharmaceuticals | Results Dupixent® (dupilumab) Late-Breaking Phase 3 Data Presented at UEG Week 2022 Showed Significant Histological Remission of Eosinophilic Esophagitis (EoE) in Children 1 to 11 Years Old regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today presented late-breaking positive results from a Phase 3 trial evaluating the investigational use of Dupixent® (dupilumab) in children aged 1 to 11 years with active eosinophilic esophagitis (EoE). |
| 2022-09-28 | Sanofi | Regulatory Press Release: Dupixent® (dupilumab) approved by FDA as the first and only treatment indicated for prurigo nodularis sanofi.com ↗
The U.S. Food and Drug Administration (FDA) has approved Dupixent ® (dupilumab) for the treatment of adult patients with prurigo nodularis. |
| 2022-09-28 | Regeneron Pharmaceuticals | Regulatory Dupixent® (dupilumab) Approved by FDA as the First and Only Treatment Indicated for Prurigo Nodularis regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for the treatment of adult patients with prurigo nodularis. |
| 2022-09-15 | Sanofi | Results Media Update: Positive Dupixent® (dupilumab) Phase 3 data in children aged 6 months to 5 years with moderate-to-severe atopic dermatitis published in The Lancet sanofi.com ↗
The Lancet has published positive results from a Phase 3 Dupixent ® (dupilumab) trial in children aged 6 months to 5 years with uncontrolled moderate-to-severe atopic dermatitis. |
| 2022-09-15 | Regeneron Pharmaceuticals | Results Positive Dupixent® (dupilumab) Phase 3 Data in Children Aged 6 Months to 5 Years with Moderate-to-severe Atopic Dermatitis Published in The Lancet regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that The Lancet has published positive results from a Phase 3 Dupixent® (dupilumab) trial in children aged 6 months to 5 years with uncontrolled moderate-to-severe atopic dermatitis. |
| 2022-09-08 | Sanofi | Results Press Release: Dupixent® (dupilumab) late-breaking Phase 3 data at EADV 2022 showed significant improvements in signs and symptoms of prurigo nodularis sanofi.com ↗
These data from one of two pivotal trials in prurigo nodularis show Dupixent significantly reduced itch and skin lesions at 24 weeks. |
| 2022-09-08 | Regeneron Pharmaceuticals | Results Dupixent® (dupilumab) Late-breaking Phase 3 Data at the EADV 2022 Congress Showed Significant Improvements in Signs and Symptoms of Prurigo Nodularis regeneron.com ↗
These data, which were consistent with the detailed data from the first Phase 3 trial (PRIME2) in prurigo nodularis, show Dupixent significantly reduced itch and skin lesions at 24 weeks. |
| 2022-09-06 | Sanofi | Results Media Update: New Dupixent® (dupilumab) data at EADV 2022 adds to body of evidence across multiple inflammatory skin diseases sanofi.com ↗
Data presentations will show dupilumab plus low-potency topical corticosteroids significantly improved quality of life and sleep quality for both children and their caregivers. |
| 2022-09-05 | Sanofi | Results Press Release: Late-breaking Dupixent® (dupilumab) data at ERS 2022 show consistent efficacy and safety profile for up to two years in children aged 6 to 11 years with moderate-to-severe asthma sanofi.com ↗
Results from the longest global Phase 3 open-label extension trial in this age group in asthma show sustained improvement in lung function, low rate of asthma attacks and a consistent safety profile for up to two years |
| 2022-09-05 | Regeneron Pharmaceuticals | Results Late-Breaking Dupixent® (dupilumab) Data at ERS 2022 Show Consistent Efficacy and Safety Profile for Up to Two Years in Children Aged 6 to 11 Years with Moderate-to-severe Asthma regeneron.com ↗
Results from the longest global Phase 3 open-label extension trial in this age group in asthma show sustained improvement in lung function, low rate of asthma attacks and a consistent safety profile for up to two years |
| 2022-08-30 | Sanofi | Results Media Update: New Dupixent® (dupilumab) data at ERS adds to body of safety and efficacy data in chronic respiratory diseases sanofi.com ↗
The safety results of this trial were generally consistent with the known safety profile of Dupixent in its respiratory indications. |
| 2022-07-14 | Sanofi | Results Press Release: Dupixent® (dupilumab) Phase 3 trial shows positive results in children 1 to 11 years of age with eosinophilic esophagitis sanofi.com ↗ |
| 2022-07-14 | Regeneron Pharmaceuticals | Results Dupixent® (dupilumab) Phase 3 Trial Shows Positive Results in Children 1 to 11 Years of Age with Eosinophilic Esophagitis regeneron.com ↗
Trial met its primary endpoint, with 68% of patients on higher dose Dupixent and 58% on lower dose Dupixent achieving histological disease remission at 16 weeks |
| 2022-06-07 | Sanofi | Regulatory Press Release: FDA approves Dupixent® (dupilumab) as first biologic medicine for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis sanofi.com ↗
The U.S. Food and Drug Administration (FDA) has approved Dupixent ® (dupilumab) for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. |
| 2022-06-07 | Regeneron Pharmaceuticals | Regulatory FDA Approves Dupixent® (dupilumab) as First Biologic Medicine for Children Aged 6 Months to 5 Years with Moderate-to-severe Atopic Dermatitis regeneron.com ↗ |
| 2022-05-31 | Sanofi | Regulatory Press Release: FDA accepts Dupixent® (dupilumab) for priority review in adults with prurigo nodularis sanofi.com ↗
The U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) to treat adults with prurigo nodularis, a chronic inflammatory skin disease that causes extreme itch and skin lesions. |
| 2022-05-31 | Regeneron Pharmaceuticals | Regulatory FDA Accepts Dupixent® (dupilumab) for Priority Review in Adults with Prurigo Nodularis regeneron.com ↗ |
| 2022-05-20 | Sanofi | Regulatory Press Release: FDA approves Dupixent® (dupilumab) as first treatment for adults and children aged 12 and older with eosinophilic esophagitis sanofi.com ↗
The U.S. Food and Drug Administration (FDA) has approved Dupixent ® (dupilumab) 300 mg weekly to treat patients with eosinophilic esophagitis (EoE) aged 12 years and older, weighing at least 40 kg. |
| 2022-05-20 | Regeneron Pharmaceuticals | Regulatory FDA Approves Dupixent® (dupilumab) as First Treatment for Adults and Children Aged 12 and Older with Eosinophilic Esophagitis regeneron.com ↗
With this approval, Dupixent becomes the first and only medicine specifically indicated to treat EoE in the United States. |
| 2022-04-07 | Sanofi | Regulatory Press Release: Dupixent® (dupilumab) approved by European Commission for children aged 6 to 11 years with severe asthma with type 2 inflammation sanofi.com ↗
The European Commission (EC) has expanded the marketing authorization for Dupixent ® (dupilumab) in the European Union. |
| 2022-04-07 | Regeneron Pharmaceuticals | Regulatory Dupixent® (dupilumab) Approved by European Commission for Children Aged 6 to 11 Years with Severe Asthma with Type 2 Inflammation regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Commission (EC) has expanded the marketing authorization for Dupixent® (dupilumab) in the European Union. |
| 2022-04-04 | Sanofi | Regulatory Press Release: FDA accepts Dupixent® (dupilumab) for Priority Review in patients aged 12 years and older with eosinophilic esophagitis sanofi.com ↗
FDA accepts Dupixent ® ( dupilumab) for Priority Review in patients aged 12 years and older with eosinophilic esophagitis |
| 2022-04-04 | Regeneron Pharmaceuticals | Regulatory FDA Accepts Dupixent® (dupilumab) for Priority Review in Patients Aged 12 Years and Older with Eosinophilic Esophagitis regeneron.com ↗ |
| 2022-03-26 | Sanofi | Results Press release: Late-breaking Phase 3 data at AAD 2022 show Dupixent® (dupilumab) significantly improved signs and symptoms of prurigo nodularis sanofi.com ↗
37% of Dupixent patients experienced a clinically meaningful reduction in itch from baseline compared to 22% of placebo patients (p=0.0216) at week 12, the primary endpoint. |
| 2022-03-26 | Regeneron Pharmaceuticals | Results Late-breaking Phase 3 Data at AAD 2022 Show Dupixent® (dupilumab) Significantly Improved Signs and Symptoms of Prurigo Nodularis regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi announced that detailed positive results from the Phase 3 PRIME2 trial evaluating the efficacy and safety of Dupixent® (dupilumab) were presented today in a late-breaking session at the American Academy of Dermatology (AAD) 2022 Annual Meeting. |
| 2022-02-26 | Sanofi | Results Late-breaking data at 2022 AAAAI Annual Meeting show Dupixent® (dupilumab) significantly improved signs and symptoms of eosinophilic esophagitis sanofi.com ↗
Positive detailed results from a second Phase 3 trial showed that Dupixent ® (dupilumab) 300 mg weekly significantly improved the signs and symptoms of eosinophilic esophagitis (EoE) at 24 weeks compared to placebo in patients 12 years and older. |
| 2022-02-26 | Sanofi | Results Late-breaking phase 3 data at 2022 AAAAI Annual Meeting show Dupixent® (dupilumab) significantly reduced itch and hives in patients with chronic spontaneous urticaria sanofi.com ↗
Detailed results from a Phase 3 trial showed that adding Dupixent ® (dupilumab) to standard-of-care antihistamines significantly reduced itch and hives at 24 weeks in biologic-naïve patients with chronic spontaneous urticaria (CSU) compared to antihistamines alone in this investigational setting. |
| 2022-02-26 | Regeneron Pharmaceuticals | Results Late-breaking Phase 3 Data at 2022 AAAAI Annual Meeting Show Dupixent® (dupilumab) Significantly Reduced Itch and Hives in Patients with Chronic Spontaneous Urticaria regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced detailed positive results for Dupixent® (dupilumab) in patients with chronic spontaneous urticaria (CSU) who are biologic-naïve (i.e., not previously treated with omalizumab). |
| 2022-02-26 | Regeneron Pharmaceuticals | Results Late-breaking Data at 2022 AAAAI Annual Meeting Show Dupixent® (dupilumab) Significantly Improved Signs and Symptoms of Eosinophilic Esophagitis regeneron.com ↗
The data from this trial showed dupilumab taken weekly not only improved patients' ability to swallow, but also reduced markers of type 2 inflammation in the esophagus, indicating its potential to address a major underlying cause of eosinophilic esophagitis. |
| 2022-02-18 | Sanofi | Results Latest Updates on Dupixent® (dupilumab) Chronic Spontaneous Urticaria Clinical Trials sanofi.com ↗
A Phase 3 trial (CUPID STUDY B) evaluating Dupixent ® (dupilumab) in patients with chronic spontaneous urticaria (CSU), who were refractory to omalizumab, will stop due to futility based on a pre-specified interim analysis. |
| 2022-02-18 | Regeneron Pharmaceuticals | Results Regeneron and Sanofi Provide Update on Ongoing Dupixent® (dupilumab) Chronic Spontaneous Urticaria Phase 3 Program regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced a Phase 3 trial (CUPID STUDY B) evaluating Dupixent® (dupilumab) in patients with chronic spontaneous urticaria (CSU) will stop due to futility, based on a pre-specified interim analysis. |
| 2022-02-10 | Sanofi | Regulatory FDA accepts Dupixent® (dupilumab) for Priority Review in children aged 6 months to 5 years with moderate-to-severe atopic dermatitis sanofi.com ↗ |
| 2022-02-10 | Regeneron Pharmaceuticals | Regulatory FDA Accepts Dupixent® (dupilumab) for Priority Review in Children Aged 6 Months to 5 Years with Moderate-to-severe Atopic Dermatitis regeneron.com ↗ |
| 2022-02-04 | Sanofi | Results Press Release: Strong 2021 sales and business EPS growth enabling increased investment in R&D sanofi.com ↗
A pivotal trial evaluating Dupixent ® for the treatment of adults with uncontrolled prurigo nodularis , met its primary and all key secondary endpoints showing that Dupixent significantly reduced itch and skin lesions compared to placebo in this investigational setting. |
| 2022-02-01 | Sanofi | Results Positive Dupixent® (dupilumab) data across five diseases with underlying type 2 inflammation to be presented at 2022 AAAAI Annual Meeting sanofi.com ↗
New pivotal data showing significant disease improvements in EoE and CSU will be presented for the first time. |
| 2022-02-01 | Regeneron Pharmaceuticals | Results Positive Dupixent® (dupilumab) Data Across Five Diseases with Underlying Type 2 Inflammation to be Presented at 2022 AAAAI Annual Meeting regeneron.com ↗
New pivotal data showing significant disease improvements in EoE and CSU will be presented for the first time. |
| 2022-01-31 | Sanofi | Regulatory CHMP recommends approval of Dupixent® (dupilumab) for children aged 6 to 11 years with severe asthma with type 2 inflammation sanofi.com ↗ |
| 2022-01-31 | Regeneron Pharmaceuticals | Regulatory CHMP Recommends Approval of Dupixent® (dupilumab) for Children Aged 6 to 11 Years with Severe Asthma with Type 2 Inflammation regeneron.com ↗ |
| 2022-01-19 | Sanofi | Results Second positive Phase 3 Dupixent® (dupilumab) trial confirms significant improvements for patients with prurigo nodularis sanofi.com ↗
A second Phase 3 trial evaluating Dupixent ® (dupilumab) in adults with uncontrolled prurigo nodularis, a chronic type 2 inflammatory skin disease, met its primary and key secondary endpoints, showing it significantly reduced itch and skin lesions compared to placebo at 24 weeks in this investigational setting. |
| 2022-01-19 | Regeneron Pharmaceuticals | Results Second Positive Phase 3 Dupixent® (dupilumab) Trial Confirms Significant Improvements for Patients with Prurigo Nodularis regeneron.com ↗
The trial met its primary and key secondary endpoints, showing that Dupixent significantly reduced itch and skin lesions compared to placebo at 24 weeks in this investigational setting. |
| 2021-12-13 | Sanofi | Results Positive Phase 3 Dupixent® (dupilumab) data in children 6 months to 5 years with moderate-to-severe atopic dermatitis featured in RAD 2021 late-breaking session sanofi.com ↗ |
| 2021-12-13 | Regeneron Pharmaceuticals | Results Positive Phase 3 Dupixent® (dupilumab) Data in Children 6 Months to 5 Years with Moderate-to-severe Atopic Dermatitis Featured in RAD 2021 Late-breaking Session regeneron.com ↗
Dupixent significantly improved skin clearance and reduced overall disease severity and itch in pivotal trial that met all primary and secondary endpoints |
| 2021-12-08 | Sanofi | Results New England Journal of Medicine publishes positive Phase 3 Dupixent® (dupilumab) results in children with moderate-to-severe asthma sanofi.com ↗
The New England Journal of Medicine has published positive results from a pivotal Dupixent ® (dupilumab) clinical trial in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. |
| 2021-12-08 | Regeneron Pharmaceuticals | Results New England Journal of Medicine Publishes Positive Phase 3 Dupixent® (dupilumab) Results in Children with Moderate-to-severe Asthma regeneron.com ↗
Dupixent significantly reduced severe asthma attacks and improved lung function and asthma control in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma |
| 2021-10-28 | Sanofi | Results Sanofi: Strong Q3 performance drives guidance upgrade to around 14% business EPS growth at CER(1) sanofi.com ↗
The data show adding Dupixent ® to standard of care topical corticosteroids (TCS) significantly reduced the overall disease severity and improved the skin clearance, itch and health-related quality of life measures at 16 weeks compared to TCS alone. |
| 2021-10-25 | Sanofi | Results Second Dupixent® (dupilumab) Phase 3 eosinophilic esophagitis trial to demonstrate significant disease improvements, underscoring role of type 2 inflammation in this complex disease sanofi.com ↗
Dupixent 300 mg weekly significantly improved the ability to swallow and reduced eosinophils in the esophagus compared to placebo, reinforcing positive results from first Phase 3 trial |
| 2021-10-25 | Regeneron Pharmaceuticals | Results Second Dupixent® (dupilumab) Phase 3 Eosinophilic Esophagitis Trial to Demonstrate Significant Disease Improvements, Underscoring Role of Type 2 Inflammation in This Complex Disease regeneron.com ↗
The trial met its co-primary endpoints in patients taking Dupixent 300 mg weekly, showing significant improvements in clinical (Dysphagia Symptom Questionnaire) and histologic disease measures compared to placebo. |
| 2021-10-22 | Sanofi | Results Dupixent® (dupilumab) is the first biologic to significantly reduce itch and skin lesions in Phase 3 trial for prurigo nodularis, demonstrating the role of type 2 inflammation in this disease sanofi.com ↗
Pivotal trial met primary and all key secondary endpoints |
| 2021-10-22 | Regeneron Pharmaceuticals | Results Dupixent® (dupilumab) is the First Biologic to Significantly Reduce Itch and Skin Lesions in Phase 3 Trial for Prurigo Nodularis, Demonstrating the Role of Type 2 Inflammation in this Disease regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced positive pivotal Phase 3 results from a trial evaluating Dupixent® (dupilumab) in adults with uncontrolled prurigo nodularis, a chronic type 2 inflammatory skin disease that causes extreme itch and skin lesions. |
| 2021-10-20 | Sanofi | Regulatory Press Release: FDA expands approval of Dupixent® (dupilumab) to include children aged 6 to 11 years with moderate-to-severe asthma sanofi.com ↗
The U.S. Food and Drug Administration (FDA) has approved Dupixent ® (dupilumab) as an add-on maintenance treatment of patients aged 6 to 11 years with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid-dependent asthma. |
| 2021-10-20 | Regeneron Pharmaceuticals | Regulatory FDA Expands Approval of Dupixent® (dupilumab) to Include Children Aged 6 to 11 Years with Moderate-to-severe Asthma regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) as an add-on maintenance treatment of patients aged 6 to 11 years with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid-dependent asthma. |
| 2021-09-30 | AbbVie | Results AbbVie Presents New Analyses Evaluating RINVOQ® (upadacitinib) in Atopic Dermatitis Across Patient Characteristics and Body Regions at EADV Virtual Congress abbvie.com ↗
An additional analysis showed more patients treated with RINVOQ 30 mg achieved EASI 75 at week 16 compared to dupilumab when measured in four body regions. |
| 2021-08-30 | Sanofi | Results Dupixent® (dupilumab) pivotal trial meets all primary and secondary endpoints becoming first biologic medicine to significantly reduce signs and symptoms of moderate-to-severe atopic dermatitis in children as young as 6 months sanofi.com ↗
A pivotal Phase 3 trial evaluating Dupixent ® (dupilumab) for the treatment of children aged 6 months to 5 years with moderate-to-severe atopic dermatitis, a chronic type 2 inflammatory disease, met its primary and all secondary endpoints. |
| 2021-08-30 | Pfizer | Results Positive Top-Line Results From Pfizer’s Phase 3 JADE DARE Trial Comparing the Efficacy of Abrocitinib and Dupilumab for Moderate to Severe Atopic Dermatitis pfizer.com ↗
The study showed that abrocitinib was statistically superior compared to dupilumab in each evaluated efficacy measure and had a safety profile consistent with previous studies. |
| 2021-08-30 | Regeneron Pharmaceuticals | Results Dupixent® (dupilumab) Pivotal Trial Meets All Primary and Secondary Endpoints Becoming First Biologic Medicine to Significantly Reduce Signs and Symptoms of Moderate-to-severe Atopic Dermatitis in Children as Young as 6 Months regeneron.com ↗
The trial met its primary and all secondary endpoints, showing that Dupixent added to standard-of-care topical corticosteroids (TCS) significantly reduced overall disease severity and improved skin clearance, itch and health-related quality of life measures at 16 weeks compared to TCS alone (placebo). |
| 2021-08-04 | AbbVie | Results JAMA Dermatology Publishes Data Showing RINVOQ® (upadacitinib) Achieved Superiority Versus DUPIXENT® (dupilumab) for Primary and All Ranked Secondary Endpoints in Phase 3b Head-to-Head Study in Adults with Atopic Dermatitis abbvie.com ↗
Of those treated with upadacitinib, 71 percent achieved EASI 75 at week 16 compared to 61 percent of those treated with dupilumab. |
| 2021-07-29 | Sanofi | Results Dupixent® (dupilumab) significantly improved itch and hives in patients with chronic spontaneous urticaria, a step forward in demonstrating the role of type 2 inflammation in these patients sanofi.com ↗
A pivotal Phase 3 trial evaluating Dupixent ® (dupilumab) in patients with moderate-to-severe chronic spontaneous urticaria (CSU), an inflammatory skin disease, met its primary endpoints and all key secondary endpoints at 24 weeks. |
| 2021-07-29 | Regeneron Pharmaceuticals | Results Dupixent® (dupilumab) Significantly Improved Itch and Hives in Patients with Chronic Spontaneous Urticaria, a Step Forward in Demonstrating the Role of Type 2 Inflammation in These Patients regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced a pivotal Phase 3 trial evaluating Dupixent® (dupilumab) in patients with moderate-to-severe chronic spontaneous urticaria (CSU) met its primary and all key secondary endpoints at 24 weeks. |
| 2021-06-28 | Sanofi | Regulatory Press Release: Dupixent® (dupilumab) SmPC updated with long-term data reinforcing well-established safety profile in adults with moderate-to-severe atopic dermatitis sanofi.com ↗
Long-term safety data from a study of adults with moderate-to-severe atopic dermatitis treated with Dupixent will be added to the Dupixent Summary of Product Characteristics (SmPC) following a positive opinion issued by the European Medicines Agency’s Committee for Medicinal Products for Human Use. |
| 2021-06-28 | Regeneron Pharmaceuticals | Regulatory Dupixent® (dupilumab) SmPC Updated with Long-term Data Reinforcing Well-established Safety Profile in Adults with Moderate-to-severe Atopic Dermatitis regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Medicines Agency will update the Dupixent® (dupilumab) summary of product characteristics (SmPC) adding long-term safety results for adults with moderate-to-severe atopic dermatitis based on a positive opinion by the Committee for Medicinal Products for Human Use (CHMP). |
| 2021-05-17 | Sanofi | Results Pivotal data at ATS 2021 show Dupixent® (dupilumab) significantly reduced asthma attacks and improved lung function in children sanofi.com ↗
Detailed results from a Phase 3 trial showed Dupixent ® (dupilumab) significantly reduced severe asthma attacks, and within two weeks rapidly improved lung function in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma, with evidence of type 2 inflammation. |
| 2021-05-17 | Regeneron Pharmaceuticals | Results Pivotal Data at ATS 2021 Show Dupixent® (dupilumab) Significantly Reduced Asthma Attacks and Improved Lung Function in Children regeneron.com ↗ |
| 2021-05-03 | Regeneron Pharmaceuticals | Results ATS 2021 Breaking News Session to Feature Pivotal Data on REGEN-COV™ (casirivimab with imdevimab) and Dupixent® (dupilumab) regeneron.com ↗
Session to also include presentation of positive Phase 3 results from Dupixent trial in children with moderate-to-severe asthma |
| 2021-04-23 | Sanofi | Results New Dupixent® (dupilumab) analyses reinforce long-term safety and efficacy profile in patients with atopic dermatitis as young as 6 years sanofi.com ↗ |
| 2021-03-04 | Sanofi | Regulatory FDA accepts Dupixent® (dupilumab) for review in children with moderate-to-severe asthma sanofi.com ↗
The U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Dupixent ® (dupilumab) as an add-on treatment for children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. |
| 2021-03-04 | Regeneron Pharmaceuticals | Regulatory FDA Accepts Dupixent® (dupilumab) for Review in Children with Moderate-to-severe Asthma regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) as an add-on treatment for children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. |
| 2021-02-01 | Sanofi | Results Media Update: New Dupixent® (dupilumab) data showcasing improvements across four type 2 inflammatory diseases to be presented at 2021 AAAAI Annual Meeting sanofi.com ↗
Improvements were noted across key disease measures in certain patients with asthma, atopic dermatitis, eosinophilic esophagitis and chronic rhinosinusitis with nasal polyposis |
| 2021-02-01 | Regeneron Pharmaceuticals | Results New Dupixent® (dupilumab) Data Showcasing Improvements Across Four Type 2 Inflammatory Diseases to be Presented at 2021 AAAAI Annual Meeting regeneron.com ↗
Improvements were noted across key disease measures in certain patients with asthma, atopic dermatitis, eosinophilic esophagitis and chronic rhinosinusitis with nasal polyposis |
| 2020-12-10 | AbbVie | Results RINVOQ™ (upadacitinib) Achieved Superiority Versus DUPIXENT® (dupilumab) For Primary and All Ranked Secondary Endpoints in Phase 3b Head-to-Head Study in Adults with Atopic Dermatitis abbvie.com ↗
Upadacitinib also showed superiority compared to dupilumab for all ranked secondary endpoints, including additional measures of skin clearance and itch reduction. |
| 2020-11-30 | Sanofi | Regulatory Dupixent® (dupilumab) approved by European Commission as first and only biologic medicine for children aged 6 to 11 years with severe atopic dermatitis sanofi.com ↗
The European Commission (EC) has extended the marketing authorization for Dupixent ® (dupilumab) in the European Union (EU) to include children 6 to 11 years of age with severe atopic dermatitis who are candidates for systemic therapy. |
| 2020-11-30 | Regeneron Pharmaceuticals | Regulatory Dupixent® (dupilumab) Approved by European Commission as First and Only Biologic Medicine for Children Aged 6 to 11 Years with Severe Atopic Dermatitis regeneron.com ↗
Dupixent is the only systemic medicine approved in the EU to treat these patients. |
| 2020-10-29 | Sanofi | Results Safety and efficacy of Dupixent® (dupilumab) in patients as young as 6 years with moderate-to-severe atopic dermatitis further reinforced by new data analyses presented at EADV sanofi.com ↗
These data reinforce the well-established long-term safety profile of Dupixent in moderate-to-severe atopic dermatitis, which does not require initial blood testing or ongoing laboratory monitoring. |
| 2020-10-29 | Regeneron Pharmaceuticals | Results Dupixent® (dupilumab) Efficacy and Safety in Patients as Young as Six Years with Moderate-to-severe Atopic Dermatitis Further Reinforced by New Analyses Presented at EADV regeneron.com ↗
These new analyses presented at EADV show Dupixent improved debilitating atopic dermatitis skin lesions, as well as symptoms like itch and sleep disturbance quickly, with sustained effects across multiple age groups, |
| 2020-10-26 | Sanofi | Results Dupixent® (dupilumab) late-breaking pivotal data showing significant improvement in eosinophilic esophagitis signs and symptoms presented for the first time at scientific meetings sanofi.com ↗
Additional positive results were announced from Part A of a pivotal Phase 3 trial evaluating the investigational use of Dupixent ® (dupilumab) in patients 12 years and older with eosinophilic esophagitis (EoE). |
| 2020-10-26 | Regeneron Pharmaceuticals | Results Dupixent® (dupilumab) Late-breaking Pivotal Data Showing Significant Improvement in Eosinophilic Esophagitis Signs and Symptoms Presented for the First Time at Scientific Meetings regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced additional positive results from Part A of a pivotal Phase 3 trial evaluating the investigational use of Dupixent® (dupilumab) in patients 12 years and older with eosinophilic esophagitis (EoE). |
| 2020-10-16 | Sanofi | Regulatory CHMP recommends approval of Dupixent® (dupilumab) for children aged 6 to 11 years with severe atopic dermatitis sanofi.com ↗
CHMP recommends approval of Dupixent® (dupilumab) for children aged 6 to 11 years with severe atopic dermatitis |
| 2020-10-16 | Regeneron Pharmaceuticals | Regulatory CHMP Recommends Approval of Dupixent® (dupilumab) for Children Aged 6 to 11 Years with Severe Atopic Dermatitis regeneron.com ↗ |
| 2020-10-13 | Sanofi | Results Dupixent® (dupilumab) significantly reduced severe asthma attacks in children and is the only biologic to demonstrate improvement in children’s lung function in a randomized Phase 3 trial sanofi.com ↗
Dupixent ® (dupilumab) significantly reduced severe asthma attacks in children and is the only biologic to demonstrate improvement in children’s lung function in a randomized Phase 3 trial |
| 2020-10-13 | Regeneron Pharmaceuticals | Results Dupixent® (dupilumab) Significantly Reduced Severe Asthma Attacks in Children and is the Only Biologic to Demonstrate Improvement in Children's Lung Function in a Randomized Phase 3 Trial regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that a pivotal Phase 3 trial of Dupixent® (dupilumab) met its primary and all key secondary endpoints in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. |
| 2020-09-14 | Sanofi | Regulatory FDA grants Dupixent® (dupilumab) Breakthrough Therapy designation for eosinophilic esophagitis sanofi.com ↗
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Dupixent ® (dupilumab) for the treatment of patients 12 years and older with eosinophilic esophagitis (EoE). |
| 2020-09-14 | Regeneron Pharmaceuticals | Regulatory FDA Grants Dupixent® (dupilumab) Breakthrough Therapy Designation for Eosinophilic Esophagitis regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Dupixent® (dupilumab) for the treatment of patients 12 years and older with eosinophilic esophagitis (EoE). |
| 2020-09-08 | Sanofi | Results Dupixent® (dupilumab) long-term data show sustained improvement in lung function and reduction in severe exacerbations in adults and adolescents with moderate-to-severe asthma sanofi.com ↗
New results from a Dupixent® (dupilumab) Phase 3 open-label extension trial showed that the safety and efficacy profile observed in previous Dupixent trials were maintained for up to three years in adults and adolescents with moderate-to-severe asthma. |
| 2020-09-08 | Regeneron Pharmaceuticals | Results Dupixent® (dupilumab) Long-term Data Show Sustained Improvement in Lung Function and Reduction in Severe Exacerbations in Adults and Adolescents with Moderate-to-severe Asthma regeneron.com ↗
These data suggest Dupixent may slow the progressive decline in lung function that many patients with moderate-to-severe asthma experience, as shown by the sustained improvement in lung function for up to three years. |
| 2020-06-19 | Sanofi | Regulatory Dupixent® (dupilumab) approved in China for adults with moderate-to-severe atopic dermatitis sanofi.com ↗
The National Medical Products Administration (NMPA) in China has approved Dupixent ® (dupilumab) for the treatment of moderate-to-severe atopic dermatitis in adults whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. |
| 2020-06-19 | Regeneron Pharmaceuticals | Regulatory FDA Approves New Dupixent® (dupilumab) Pre-filled Pen Designed to Support More Convenient Self-Administration regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved a 300 mg single-dose pre-filled pen for Dupixent® (dupilumab). |
| 2020-06-19 | Regeneron Pharmaceuticals | Regulatory Dupixent® (dupilumab) Approved in China for Adults with Moderate-to-Severe Atopic Dermatitis regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the National Medical Products Administration (NMPA) in China has approved Dupixent® (dupilumab) for the treatment of moderate-to-severe atopic dermatitis in adults whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. |
| 2020-06-11 | Regeneron Pharmaceuticals | Results Regeneron Collaborations on Dupixent® (dupilumab) Highlighted During Sanofi R&D Investor Event regeneron.com ↗
An ongoing Phase 3 trial in approximately 900 COPD patients with evidence of type 2 inflammation recently met a blinded, stringent early efficacy threshold for continuation, and based on this result a second confirmatory trial will commence in the third quarter of 2020. |
| 2020-05-26 | Sanofi | Regulatory Sanofi: FDA approves Dupixent® (dupilumab) as first biologic medicine for children aged 6 to 11 years with moderate-to-severe atopic dermatitis sanofi.com ↗
The U.S. Food and Drug Administration (FDA) approved Dupixent ® (dupilumab) for children aged 6 to 11 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. |
| 2020-05-26 | Regeneron Pharmaceuticals | Regulatory FDA Approves Dupixent® (dupilumab) as First Biologic Medicine for Children Aged 6 to 11 Years with Moderate-to-Severe Atopic Dermatitis regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for children aged 6 to 11 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. |
| 2020-05-22 | Sanofi | Results Dupixent® (dupilumab) eosinophilic esophagitis trial meets both co-primary endpoints sanofi.com ↗
Sanofi and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive results from Part A of the pivotal Phase 3 trial evaluating Dupixent ® (dupilumab) in patients 12 years and older with eosinophilic esophagitis (EoE). |
| 2020-05-22 | Regeneron Pharmaceuticals | Results Dupixent® (dupilumab) Eosinophilic Esophagitis Trial Meets Both Co-Primary Endpoints regeneron.com ↗
The trial met both of its co-primary endpoints, as well as all key secondary endpoints. |
| 2020-04-03 | Sanofi | Results Sanofi: Dupixent® (dupilumab) Phase 3 data show significant improvement in severe atopic dermatitis for children aged 6 to 11 years sanofi.com ↗
The pivotal Phase 3 clinical trial results announced today show Dupixent ® (dupilumab) combined with standard-of-care topical corticosteroids (TCS) in children aged 6-11 years with uncontrolled severe atopic dermatitis significantly improved disease signs, symptoms and health-related quality of life. |
| 2020-04-03 | Regeneron Pharmaceuticals | Results Dupixent® (dupilumab) Phase 3 Data at Revolutionizing Atopic Dermatitis Conference Show Significant Improvement in Severe Atopic Dermatitis for Children Aged 6 to 11 Years regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced detailed positive results from a pivotal Phase 3 trial evaluating Dupixent® (dupilumab) for children aged 6 to 11 years with uncontrolled severe atopic dermatitis. |
| 2020-03-18 | Pfizer | Results Pfizer Announces Positive Top-Line Results from Third Phase 3 Trial of Abrocitinib for Moderate to Severe Atopic Dermatitis, Which Showed Improvements in Skin Clearance, Disease Extent and Severity, and Itch pfizer.com ↗
Dupilumab, the active control on these primary endpoints, demonstrated superiority to placebo at Week 12 and Week 16. |
| 2020-03-18 | Pfizer | Results Pfizer Announces Positive Top-Line Results from Third Phase 3 Trial of Abrocitinib for Moderate to Severe Atopic Dermatitis, Which Showed Improvements in Skin Clearance, Disease Extent and Severity, and Itch pfizer.com ↗
Dupilumab, the active control on these primary endpoints, demonstrated superiority to placebo at Week 12 and Week 16. |
| 2020-01-28 | Sanofi | Regulatory Sanofi : FDA accepts for priority review Dupixent® (dupilumab) for children aged 6 to 11 years with moderate-to-severe atopic dermatitis sanofi.com ↗
FDA accepts for priority review Dupixent ® (dupilumab) for children aged 6 to 11 years with moderate-to-severe atopic dermatitis |
| 2020-01-28 | Regeneron Pharmaceuticals | Regulatory FDA Accepts for Priority Review Dupixent® (dupilumab) for Children Aged 6 to 11 Years with Moderate-to-Severe Atopic Dermatitis regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) as an add-on maintenance treatment for children aged 6 to 11 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. |
| 2019-10-29 | Regeneron Pharmaceuticals | Regulatory Dupixent® (dupilumab) Now Approved in European Union for Severe Chronic Rhinosinusitis with Nasal Polyposis regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Commission (EC) has approved a new indication for Dupixent® (dupilumab) in chronic rhinosinusitis with nasal polyposis (CRSwNP). |
| 2019-09-20 | Regeneron Pharmaceuticals | Results The Lancet Publishes Results from Two Positive Phase 3 Trials of Dupixent® (dupilumab) in Severe Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) regeneron.com ↗
Results published in The Lancet demonstrated that adding Dupixent to the standard-of-care corticosteroid nasal spray reduced nasal polyp size and nasal congestion severity (co-primary endpoints). |
| 2019-09-20 | Regeneron Pharmaceuticals | Regulatory CHMP Recommends Approval of Dupixent® (dupilumab) for Severe Chronic Rhinosinusitis with Nasal Polyposis regeneron.com ↗
The CHMP recommended Dupixent be approved as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe chronic rhinosinusitis with nasal polyposis (CRSwNP) for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. |
| 2019-08-06 | Regeneron Pharmaceuticals | Results Dupixent® (dupilumab) Showed Positive Topline Results in Phase 3 Trial of Children Aged 6 to 11 Years with Severe Atopic Dermatitis regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that a pivotal Phase 3 trial evaluating Dupixent® (dupilumab) to treat severe atopic dermatitis in children aged 6 to 11 years met its primary and secondary endpoints. |
| 2019-08-06 | Regeneron Pharmaceuticals | Regulatory Dupixent® (dupilumab) Approved by European Commission for Adolescents with Moderate-to-Severe Atopic Dermatitis regeneron.com ↗
Dupixent is now the first biologic medicine approved in the EU to treat these patients. |
| 2019-06-28 | Regeneron Pharmaceuticals | Regulatory CHMP Recommends Approval of Dupixent® (dupilumab) for Moderate-to-Severe Atopic Dermatitis in Adolescents regeneron.com ↗
has adopted a positive opinion for Dupixent® (dupilumab), recommending to extend its approval in the European Union (EU) to include adolescents 12 to 17 years of age with moderate-to-severe atopic dermatitis who are candidates for systemic therapy. |
| 2019-06-26 | Regeneron Pharmaceuticals | Regulatory FDA Approves Dupixent® (dupilumab) for Chronic Rhinosinusitis with Nasal Polyposis regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for use with other medicines to treat chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults whose disease is not controlled. |
| 2019-06-21 | Regeneron Pharmaceuticals | Results Regeneron and Sanofi Announce Positive Topline Phase 2 Results for IL-33 Antibody in Asthma regeneron.com ↗
Patients treated with Dupixent® (dupilumab) monotherapy did numerically better than REGN3500 across all endpoints, although the trial was not powered to show differences between active treatment arms. |
| 2019-05-07 | Regeneron Pharmaceuticals | Regulatory Regeneron Reports First Quarter 2019 Financial and Operating Results regeneron.com ↗
FDA approved Dupixent for moderate-to-severe atopic dermatitis in adolescents |
| 2019-05-07 | Regeneron Pharmaceuticals | Regulatory Dupixent® (dupilumab) Approved for Severe Asthma by European Commission regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Commission (EC) approved a new indication for Dupixent® (dupilumab) in asthma. |
| 2019-03-11 | Regeneron Pharmaceuticals | Regulatory FDA Approves Dupixent® (dupilumab) for Moderate-to-severe Atopic Dermatitis in Adolescents regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. |
| 2019-03-08 | Regeneron Pharmaceuticals | Regulatory FDA to Undertake Priority Review of Dupixent® (dupilumab) for Adults with Inadequately Controlled Severe Chronic Rhinosinusitis with Nasal Polyps regeneron.com ↗ |
| 2019-03-01 | Regeneron Pharmaceuticals | Regulatory CHMP Recommends Approval of Dupixent® (dupilumab) for Asthma Indication regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Medicines Agency'sCommittee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Dupixent® (dupilumab) in asthma. |
| 2019-02-25 | Regeneron Pharmaceuticals | Results Positive Results Presented from Two Phase 3 Trials of Dupixent® (dupilumab) in Severe Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) regeneron.com ↗
These trials, known as SINUS-24 and SINUS-52, demonstrated that Dupixent® (dupilumab), when added to the standard-of-care corticosteroid nasal spray, improved nasal polyp size, nasal congestion severity, chronic sinus disease, sense of smell and co-morbid asthma outcomes. |
| 2018-11-06 | Regeneron Pharmaceuticals | Regulatory FDA Grants Priority Review for Dupixent® (dupilumab) as Potential Treatment for Adolescents with Uncontrolled Moderate-to-Severe Atopic Dermatitis regeneron.com ↗
the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) |
| 2018-10-19 | Regeneron Pharmaceuticals | Regulatory FDA Approves Asthma Indication for Dupixent® (dupilumab) regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced the U.S. Food and Drug Administration has approved Dupixent® (dupilumab) as an add-on maintenance therapy in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid-dependent asthma. |
| 2018-10-16 | Regeneron Pharmaceuticals | Results Dupixent® (dupilumab) Showed Positive Topline Results in Two Phase 3 Trials of Patients with Chronic Rhinosinusitis with Nasal Polyps regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that both pivotal Phase 3 placebo-controlled trials evaluating Dupixent® (dupilumab) in adults with inadequately-controlled chronic rhinosinusitis with nasal polyps ("CRSwNP"), met all their primary and secondary endpoints. |
| 2018-09-15 | Regeneron Pharmaceuticals | Results Positive Phase 3 Results Presented for Dupixent® (dupilumab) Show Significant Improvement on Multiple Measures of Disease Severity in Adolescents with Moderate-to-Severe Atopic Dermatitis regeneron.com ↗
Results on skin clearing, itch and certain quality of life measurements were presented today as a late-breaking oral presentation at the 27th EADV Congress |
| 2018-05-21 | Regeneron Pharmaceuticals | Results New England Journal of Medicine Publishes Two Positive Phase 3 Trials Showing DUPIXENT® (dupilumab) Improved Moderate-to-Severe Asthma regeneron.com ↗
The results showed that DUPIXENT significantly reduced the risk of severe asthma attacks (exacerbations), improved lung function and reduced dependence on oral corticosteroids (OCS). |
| 2018-05-16 | Regeneron Pharmaceuticals | Results Positive Phase 3 Trial of DUPIXENT® (dupilumab) in Adolescents with Inadequately Controlled Moderate-to-severe Atopic Dermatitis regeneron.com ↗
In the trial, treatment with DUPIXENT as monotherapy significantly improved measures of overall disease severity, skin clearing, itching and certain health-related quality of life measures. |
| 2018-04-03 | Regeneron Pharmaceuticals | Regulatory EMA to Review DUPIXENT® (dupilumab) as Potential Treatment for Inadequately Controlled Moderate-to-Severe Asthma regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Medicines Agency (EMA) has accepted for review an application for DUPIXENT® (dupilumab) as an add-on maintenance treatment in certain adults and adolescents (12 years of age and older) with inadequately controlled moderate-to-severe asthma. |
| 2018-03-02 | Regeneron Pharmaceuticals | Regulatory FDA to Review DUPIXENT® (dupilumab) as Potential Treatment for Moderate-to-Severe Asthma regeneron.com ↗
that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) of DUPIXENT® (dupilumab) as an add-on maintenance treatment in certain adults and adolescents (12 years of age and older) with moderate-to-severe asthma. |
| 2018-01-22 | Regeneron Pharmaceuticals | Regulatory Regeneron Announces Approval of DUPIXENT® (dupilumab) in Japan for the Treatment of Atopic Dermatitis regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the Ministry of Health, Labor and Welfare (MHLW) in Japan has granted marketing and manufacturing authorization for DUPIXENT® (dupilumab) for the treatment of atopic dermatitis in adults not adequately controlled with existing therapies. |
| 2017-10-31 | Regeneron Pharmaceuticals | Results Dupilumab Significantly Reduced Steroid Use, Asthma Attacks, and Improved Lung Function in Phase 3 Study of People with Severe Steroid-Dependent Asthma regeneron.com ↗ |
| 2017-10-16 | Regeneron Pharmaceuticals | Results Regeneron and Sanofi Announce Positive Phase 2 Study Results for Dupilumab in Patients With Active Moderate-to-Severe Eosinophilic Esophagitis regeneron.com ↗
The study showed that patients who received dupilumab weekly reported a significant improvement in the ability to swallow versus placebo. |
| 2017-09-28 | Regeneron Pharmaceuticals | Regulatory Regeneron and Sanofi Announce Approval of DUPIXENT® (dupilumab) to Treat Adult Patients with Moderate-to-Severe Atopic Dermatitis in the European Union regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Commission (EC) has granted marketing authorization for DUPIXENT® (dupilumab), for use in adults with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy. |
| 2017-09-16 | Regeneron Pharmaceuticals | Results Regeneron and Sanofi Announce Positive Study Results for DUPIXENT® (dupilumab) in Patients With Moderate-to-Severe Atopic Dermatitis regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced positive results from the Phase 3 CAFÉ study of DUPIXENT® (dupilumab) in adults with moderate-to-severe atopic dermatitis (AD) who are inadequately controlled with or are intolerant to the broad immunosuppressant drug cyclosporine A (CSA), or when this treatment is medically inadvisable. |
| 2017-09-11 | Regeneron Pharmaceuticals | Results Regeneron and Sanofi Announce Positive Dupilumab Topline Results from Phase 3 Trial in Uncontrolled Persistent Asthma regeneron.com ↗
Dupilumab, when added to standard therapies, reduced severe asthma attacks (exacerbations) and improved lung function. |
All press releases naming this drug 251 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 251 releases opens the full record — a long page | ||
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 213 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Dupilumab | “Patients with moderate to severe atopic dermatitis refractory to topical medication, who also have previous experience with cyclosporine and an unsatisfactory response, or in...” NCT06366932 ↗199“Effect of Dupilumab on Sleep Disturbance in Patients With Uncontrolled Moderate-to-Severe Asthma, Type 2 Inflammation, and Nocturnal Awakenings: The MORPHEO Randomized Controlled Trial.” PMID 42370853 ↗ Jun 2026 “ICIs：Nivolumab/Pembrolizumab/Durvalumab/Atezolizumab/ Camrelizumab/Dupilumab/Sintilimab/Tislelizumab：administrated for patients with NSCLC requiring post-operative adjuvant therapy.” NCT05834413 ↗ “Dupilumab is a fully human monoclonal antibody directed against the interleukin (IL)-4 receptor α subunit (IL-4Rα) of IL-4 heterodimeric type I and type II receptors” PMID 32348036 ↗ Apr 2020 “Dupilumab is a fully human monoclonal antibody that blocks the receptor component for IL-4 and IL-13, which are key drivers of type 2 inflammation.” NCT05031455 ↗ “Three biologic medications have been FDA approved and available for the treatment of CRSwNP: dupilumab, omalizumab, and mepolizumab.” NCT06824649 ↗ “the effect of omalizumab (Xolair) and dupilumab (Dupixent) on markers of eosinophilic inflammation” NCT04943744 ↗ “receiving mepolizumab (100 mg) or dupilumab (300 mg) every 4 weeks” NCT07187583 ↗ “U.S. commercial dupilumab (Dupixent®)” NCT07411755 ↗ |
| Known as | Dupixent | “This proposal is for a Window of Opportunity (WOO) clinical trial using a novel combination of two Health Canada approved agents, cemiplimab (Libtayo) and dupilumab (Dupixent),...” NCT05967884 ↗22“Dupilumab (DUPIXENT) is indicated for the treatment of children of 6 years and older with moderate-to-sever atopic dermatitis whos disease is not adequately controlled with...” NCT04878770 ↗ “Dupilumab (Dupixent) is a human monoclonal antibody administered via subcutaneous injection to treat various conditions such as Chronic Rhinosinusitis with Nasal Polyps, Asthma...” NCT06461949 ↗ “Dupilumab (Dupixent®), a monoclonal antibody inhibiting the IL-4 and IL-13 pathway by targeting the IL-4-receptor, has been approved for the treatment of moderate-to-severe...” NCT04600362 ↗ “A Study to Evaluate the Biosimilarity of GLR1044 Injection and Dupilumab Injection (Dupixent®) in Healthy Adult Male Subjects” NCT07334496 ↗ “the effect of omalizumab (Xolair) and dupilumab (Dupixent) on markers of eosinophilic inflammation” NCT04943744 ↗ “Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]” NCT04430179 ↗ “Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]” NCT06665971 ↗ “Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]” NCT07358234 ↗ “Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]” NCT04869436 ↗ “U.S. commercial dupilumab (Dupixent®)” NCT07411755 ↗ |
| Known as | REGN668 | “Drug: Dupilumab SAR231893 (REGN668)” NCT02898454 ↗6“Dupilumab SAR231893 (REGN668)” NCT02912468 ↗ “Dupilumab SAR231893 (REGN668)” NCT03620747 ↗ “Dupilumab (SAR231893/REGN668)” NCT03560466 ↗ “SAR231893 (REGN668)” NCT01537653 ↗ |
| Known as | Regn668, sar231893 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108675 ↗ |
| Known as | SAR231893 | “Sequential Ascending Dose Study to Assess the Safety and Tolerability of REGN668 (SAR231893) in Patients With Atopic Dermatitis” NCT01259323 ↗16“Drug: Dupilumab SAR231893 (REGN668)” NCT02898454 ↗ “Dupilumab SAR231893 (REGN668)” NCT02912468 ↗ “Dupilumab SAR231893 (REGN668)” NCT03620747 ↗ “Dupilumab (SAR231893/REGN668)” NCT03560466 ↗ “Drug: Dupilumab (SAR231893)” NCT05976386 ↗ “Dupilumab (SAR231893)” NCT04823130 ↗ “Dupilumab (SAR231893)” NCT05976360 ↗ “Dupilumab (SAR231893)” NCT05976373 ↗ “Dupilumab SAR231893” NCT03782532 ↗ “Dupilumab SAR231893” NCT04681729 ↗ |
| Known as | SAR231893/REGN668 | “Dupilumab SAR231893/REGN668” NCT02573233 ↗ |
| Action | Inhibit | “indicating blockade of IL-4Rα-mediated signaling” PMID 32348036 ↗ Apr 2020 |
| Modality | Monoclonal antibody | “a fully human monoclonal antibody to the alpha subunit of the interleukin-4 receptor” PMID 23688323 ↗ May 2013 |
| Route | Intravenous | “Intravenously Administered REGN668 in Healthy Volunteers” NCT01015027 ↗ |
| Target | IL4R | “Dupilumab is a fully human monoclonal antibody directed against the interleukin (IL)-4 receptor α subunit (IL-4Rα) of IL-4 heterodimeric type I and type II receptors” PMID 32348036 ↗ Apr 2020 |