Drugs / Sarilumab
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed polymyalgia rheumatica 1 milestone | |||||
| Filed | US (FDA) | Kevzara | polymyalgia rheumatica | 2023-02-03 | “The FDA accepted for priority review the sBLA for Kevzara® (sarilumab) to treat polymyalgia rheumatica (PMR)” regeneron.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (3) | US (FDA) | KEVZARA | — | 2018-04-13 – 2024-06-10 | fda.gov ↗ |
| Approved | EU (EMA) | Kevzara | — | 2017-06-23 | europa.eu ↗ |
| Approved | US (FDA) | KEVZARA | — | 2017-05-22 | fda.gov ↗ |
Trials 56
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04386239 | Jan 2021 → Jan 2023 | COVID-19 | ASST Fatebenefratelli Sacco | Withdrawn | No outcome recorded |
| Phase 110 trials | ||||||
| Phase 1 | NCT07484113 | Jul 2026 → May 2028 expected | chronic graft versus host disease | Stanford University | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT05704634 | Aug 2023 → Jan 2028 expected | lung cancer | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02404558 | May 2015 → Mar 2016 | rheumatoid arthritis | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT02097524 | Mar 2014 → Apr 2015 | rheumatoid arthritis | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02017639 | Jan 2014 → Mar 2016 | rheumatoid arthritis | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT01850680 | Apr → Dec 2013 | rheumatoid arthritis | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT01328522 | May → Sep 2011 | rheumatoid arthritis | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT06159452 | Jul → Dec 2010 | rheumatoid arthritis | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT01026519 | Sep 2008 → Mar 2009 | rheumatoid arthritis | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01055899 | Jul 2008 → Mar 2009 | rheumatoid arthritis | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/26 trials | ||||||
| Phase 1/2 | NCT07704580 | Jul 2026 → Oct 2028 expected | rheumatoid arthritis | Sanofi | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04842981 | May 2021 → Sep 2022 | rheumatoid arthritis | University of Southern Denmark | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT04590326 | Dec 2020 → Nov 2028 expected | endometrial cancer, fallopian tube cancer, ovarian cancer, primary peritoneal carcinoma | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04333706 | Sep 2020 → Nov 2026 expected | metastatic malignant neoplasm, triple-negative breast carcinoma | University of Southern California | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03679845 | Sep 2019 → Jun 2021 | localized scleroderma | Massachusetts General Hospital | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT03564340 | May 2018 → May 2027 expected | endometrial cancer, fallopian tube cancer, malignant ovarian serous tumor, primary peritoneal carcinoma | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 216 trials · 4 missed | ||||||
| Phase 2 | NCT07836101 | Oct 2026 → Aug 2029 expected | cancer | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07154290 | Mar 2026 → Jun 2030 expected | non-small cell lung carcinoma | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 2 | NCT05428007 | Feb 2023 → Aug 2026 overdue | melanoma | NYU Langone Health | Recruiting | No outcome recorded |
| Phase 2 | NCT07196306 | May → Aug 2020 | COVID-19 | BayCare Health System | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04357860 | Apr 2020 → Mar 2021 | COVID-19, severe acute respiratory syndrome | Maimónides Biomedical Research Institute of Córdoba | Completed | Missed primary |
| Phase 2 | NCT04661527 | Apr → Dec 2020 | — | Clinica Universidad de Navarra, Universidad de Navarra | Unknown | No outcome recorded |
| Phase 2 | NCT04357808 | Apr → Nov 2020 | COVID-19 | Maria del Rosario Garcia de Vicuña Pinedo | Completed | Missed primary |
| Phase 2 | NCT04322773 | Apr → Oct 2020 | COVID-19 | Marius Henriksen | Terminated | No outcome recorded |
| Phase 2 | NCT04008069 | Sep 2019 → Jul 2022 | sarcoidosis | Stanford University | Completed | No outcome recorded |
| Phase 2 | NCT02991469 | Aug 2018 → Mar 2028 expected | juvenile idiopathic arthritis | Sanofi | Recruiting | No outcome recorded |
| Phase 2 | NCT02776735 | Sep 2016 → Apr 2022 | juvenile idiopathic arthritis | Sanofi | Completed | No outcome recorded |
| Phase 2 | NCT01900431 | Oct 2013 → Jul 2015 | uveitis | Sanofi | Completed | Missed primary |
| Phase 2 | NCT01217814 | Nov 2010 → Sep 2011 | rheumatoid arthritis | Sanofi | Terminated | No outcome recorded |
| Phase 2 | NCT01118728 | Jun 2010 → Dec 2011 | ankylosing spondylitis | Sanofi | Terminated | No outcome recorded |
| Phase 2 | NCT01042379 | Mar 2010 → Dec 2030 expected | HER2 positive breast carcinoma, angiosarcoma, female breast carcinoma, hormone receptor-positive breast cancer +1 | QuantumLeap Healthcare Collaborative | Recruiting | No outcome recorded |
| Phase 2 | NCT01061723 | Feb 2010 → Jun 2011 | ankylosing spondylitis | Sanofi | Completed | Missed primary |
| Phase 2/35 trials · 1 met primary · 1 missed | ||||||
| Phase 2/3 | NCT05535738 | Nov 2022 → Jan 2027 expected | allergic contact dermatitis | Wei-Che Ko | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT04341870 | Apr → May 2020 | COVID-19 | Assistance Publique - Hôpitaux de Paris | Suspended | No outcome recorded |
| Phase 2/3 | NCT04324073 | Mar → Apr 2020 | COVID-19 | Assistance Publique - Hôpitaux de Paris | Completed | Missed primary |
| Phase 2/3 | NCT04315298 | Mar → Jul 2020 | COVID-19 | Regeneron Pharmaceuticals | Completed | Mixed |
| Phase 2/3 | NCT01061736 | Mar 2010 → Oct 2013 | rheumatoid arthritis | Sanofi | Completed | Met primary |
| Phase 313 trials · 4 met primary · 1 missed | ||||||
| Phase 3 | NCT04327388 | Mar → Jul 2020 | COVID-19 | Sanofi | Completed | Missed primary |
| Phase 3 | NCT03600818 | Oct 2018 → May 2021 | polymyalgia rheumatica | Sanofi | Terminated | Met primary Stop: Enrollment |
| Phase 3 | NCT03535402 | Jun 2018 → Dec 2020 | rheumatoid arthritis | Gaylis, Norman B., M.D. | Unknown | No outcome recorded |
| Phase 3 | NCT02735707 | Apr 2016 → Feb 2026 overdue | pneumonia | UMC Utrecht | Recruiting | Mixed |
| Phase 3 | NCT02373202 | Feb 2015 → Nov 2016 | rheumatoid arthritis | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT02332590 | Jan 2015 → Jan 2016 | rheumatoid arthritis | Sanofi | Completed | Met primary |
| Phase 3 | NCT02293902 | Nov 2014 → Oct 2016 | rheumatoid arthritis | Sanofi | Completed | Met primary |
| Phase 3 | NCT02121210 | Jun 2014 → May 2015 | rheumatoid arthritis | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT02057250 | Mar 2014 → Feb 2015 | rheumatoid arthritis | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT01764997 | Apr 2013 → Jan 2015 | rheumatoid arthritis | Sanofi | Terminated | No outcome recorded |
| Phase 3 | NCT01768572 | Mar 2013 → Oct 2014 | rheumatoid arthritis | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT01709578 | Oct 2012 → Mar 2015 | rheumatoid arthritis | Sanofi | Completed | Met primary |
| Phase 3 | NCT01146652 | Jun 2010 → Dec 2020 | rheumatoid arthritis | Sanofi | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT07286214 | May 2026 → Jun 2029 expected | polymyalgia rheumatica | Sanofi | Recruiting | No outcome recorded |
| Phase 4 | NCT04350216 | Apr → Oct 2020 | atherosclerosis, rheumatoid arthritis | Marqués de Valdecilla Research Institute (IDIVAL) | Unknown | No outcome recorded |
| Phase 4 | NCT03449758 | Mar 2018 → Jul 2019 | rheumatoid arthritis | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT02714634 | Mar 2016 → Mar 2029 expected | rheumatoid arthritis | University Hospital, Strasbourg, France | Recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT05305066 | Feb 2023 → Dec 2028 expected | rheumatoid arthritis | Marie Hudson, MD | Recruiting | No outcome recorded |
| Comparator or background therapy9 trials | ||||||
| Phase 1 | NCT01011959 Comparator | Dec 2008 → Aug 2009 | rheumatoid arthritis | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/2 | NCT07850921 Background | Jun 2027 → Jul 2031 expected | prostate carcinoma | Regeneron Pharmaceuticals | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06787612 Background | May 2025 → Jun 2028 expected | fallopian tube cancer, ovarian cancer, primary peritoneal carcinoma | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 2 | NCT04359901 Comparator | Apr 2020 → Aug 2021 | COVID-19 | Westyn Branch-Elliman | Completed | No outcome recorded |
| Phase 2 | NCT03770273 Comparator | Jun 2019 → Jul 2023 | indolent systemic mastocytosis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 3 | NCT04692493 Comparator | Sep 2021 → May 2029 expected | rheumatoid arthritis | University of Alabama at Birmingham | Recruiting | No outcome recorded |
| Phase 3 | NCT04134728 Comparator | Oct 2019 → Sep 2021 | rheumatoid arthritis | GlaxoSmithKline | Completed | Missed primary |
| Phase 3 | NCT03600805 Comparator | Nov 2018 → Nov 2020 | temporal arteritis | Sanofi | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT03414502 Comparator | Dec 2007 → Mar 2028 expected | rheumatoid arthritis | University of Nebraska | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2024-06-11 | Regeneron Pharmaceuticals | Regulatory Kevzara® (sarilumab) Approved by FDA for the Treatment of Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration has approved Kevzara® (sarilumab) for the treatment of patients weighing 63 kg or greater with active polyarticular juvenile idiopathic arthritis (pJIA), a form of arthritis that impacts multiple joints at a time. |
| 2023-02-28 | Regeneron Pharmaceuticals | Regulatory Kevzara® (sarilumab) Approved by FDA as First and Only Biologic Indicated for Patients with Polymyalgia Rheumatica regeneron.com ↗ |
| 2020-09-01 | Sanofi | Results Sanofi provides update on Kevzara® (sarilumab) Phase 3 trial in severe and critically ill COVID-19 patients outside the U.S. sanofi.com ↗
Although not statistically significant, numerical trends were observed toward a decrease in duration of hospital stay as well as an acceleration in time to improve clinical outcomes, as measured by a 2-point improvement from baseline on the 7-point scale. |
| 2020-07-02 | Sanofi | Results Sanofi and Regeneron provide update on Kevzara® (sarilumab) Phase 3 U.S. trial in COVID-19 patients sanofi.com ↗
Based on the results, the U.S.-based trial has been stopped, including in a second cohort of patients who received a higher dose of Kevzara (800 mg). |
| 2020-07-02 | Regeneron Pharmaceuticals | Results Regeneron and Sanofi Provide Update on Kevzara® (sarilumab) Phase 3 U.S. Trial in COVID-19 Patients regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Phase 3 trial of Kevzara® (sarilumab) 400 mg in COVID-19 patients requiring mechanical ventilation did not meet its primary and key secondary endpoints when Kevzara was added to best supportive care compared to best supportive care alone (placebo). |
| 2020-04-27 | Sanofi | Results Sanofi and Regeneron provide update on U.S. Phase 2/3 adaptive-designed trial in hospitalized COVID-19 patients sanofi.com ↗
Following a review by the Independent Data Monitoring Committee (IDMC) of all available Phase 2 and Phase 3 data, the trial will be immediately amended so that only “critical” patients continue to be enrolled to receive Kevzara 400 mg or placebo. |
| 2020-04-27 | Regeneron Pharmaceuticals | Results Regeneron and Sanofi Provide Update on U.S. Phase 2/3 Adaptive-Designed Trial of Kevzara® (sarilumab) in Hospitalized COVID-19 Patients regeneron.com ↗
Independent Data Monitoring Committee recommended continuing ongoing Phase 3 trial only in the more advanced "critical" group with Kevzara higher-dose versus placebo and discontinuing less advanced "severe" group |
| 2018-10-19 | Regeneron Pharmaceuticals | Results Kevzara® (sarilumab) Data at the 2018 ACR/ARHP Annual Meeting Provide Additional Insight on Safety and Efficacy in Rheumatoid Arthritis regeneron.com ↗
The incidence of treatment-emergent adverse events was similar in patients in the low, medium and high IL-6 groups. |
All press releases naming this drug 13 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 67 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Sarilumab | “Switching to a non-TNFi-biologic (choice from non-TNFi-biologics; currently available are rituximab, abatacept, tocilizumab, or sarilumab) in people with active RA despite...” NCT04692493 ↗59“Currently, there are two available drugs based on human monoclonal antibodies against IL-6 receptor, tocilizumab (RoActemra, Roche) and sarilumab (Kevzara, Sanofi).” NCT04322773 ↗ “Assess the long term safety of sarilumab in participants with rheumatoid arthritis (RA).” NCT01146652 ↗ “Tocilizumab and Sarilumab are considered equal.” NCT04842981 ↗ “Methotrexate or leflunomide + sarilumab or” NCT02714634 ↗ “sarilumab (200 mg SC once every 2 weeks)” NCT05305066 ↗ |
| Known as | Kevzara | “Sarilumab is marketed in the United States as Kevzara (Sanofi/Genzyme [Cambridge, Massachusetts, USA ]) and is approved by the Food and Drug Administration for the treatment of...” NCT03770273 ↗3“Currently, there are two available drugs based on human monoclonal antibodies against IL-6 receptor, tocilizumab (RoActemra, Roche) and sarilumab (Kevzara, Sanofi).” NCT04322773 ↗ “Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA]” NCT04350216 ↗ “sarilumab (also called Kevzara)” NCT05704634 ↗ |
| Known as | REGN88 | “Drug: sarilumab SAR153191 (REGN88)” NCT01850680 ↗11“sarilumab SAR153191 (REGN88)” NCT02121210 ↗ “Sarilumab SAR153191 (REGN88)” NCT02293902 ↗ “Sarilumab SAR153191 (REGN88)” NCT02991469 ↗ “sarilumab SAR153191 (REGN88)” NCT02404558 ↗ “Sarilumab SAR153191 (REGN88)” NCT03600818 ↗ “sarilumab SAR153191 (REGN88)” NCT01768572 ↗ “sarilumab SAR153191 (REGN88)” NCT02017639 ↗ “SAR153191 (REGN88)” NCT01328522 ↗ |
| Known as | SAR153191 | “A Multiple-dose Study of the Safety and Tolerability of REGN88(SAR153191) in Rheumatoid Arthritis Subjects” NCT01011959 ↗15“A Safety and Tolerability Study of REGN88(SAR153191) in Subjects With Rheumatoid Arthritis” NCT01026519 ↗ “Safety Study of a Single Dose of REGN88(SAR153191)in Patients With Rheumatoid Arthritis” NCT01055899 ↗ “Drug: sarilumab SAR153191 (REGN88)” NCT01850680 ↗ “sarilumab SAR153191 (REGN88)” NCT02404558 ↗ “sarilumab SAR153191 (REGN88)” NCT02121210 ↗ “Sarilumab SAR153191 (REGN88)” NCT02991469 ↗ “Sarilumab SAR153191 (REGN88)” NCT02293902 ↗ “sarilumab SAR153191 (REGN88)” NCT01768572 ↗ “sarilumab SAR153191 (REGN88)” NCT02017639 ↗ “Sarilumab SAR153191 (REGN88)” NCT03600818 ↗ |
| Action | Inhibit | “IL-6Rα blockade with sarilumab” PMID 24550171 ↗ Feb 2014 |
| Modality | Monoclonal antibody | “the first fully human monoclonal antibody against interleukin-6 receptor-α (IL-6Rα)” PMID 24550171 ↗ Feb 2014 |
| Route | Subcutaneous | “subcutaneously (SC) administered REGN88” NCT01026519 ↗ |
| Target | IL6R | “blocking the IL-6Rα” PMID 29556418 ↗ Mar 2018 |