Drugs / natalizumab
natalizumab
also known as
TYSABRI · BG00002 · Antegren · NTZ · NAT · natalizumab (Tysabri) · Tyruko · Tysabri (natalizumab)
Regulatory milestones approvals, filings & regulatory actions · 15 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed autoimmune disease, multisystem, infantile-onset 1 milestone | |||||
| Filed | US (FDA) | — | autoimmune disease, multisystem, infantile-onset | 2022-07-25 | “FDA has accepted the first-ever Biologics License Application (BLA) for natalizumab, a proposed biosimilar to Tysabri ® *, filed by their collaboration partner Sandoz.” polpharmabiologics.com ↗ “the US Food and Drug Administration (FDA) has accepted its biologics license application (BLA) for a proposed first-of-a-kind biosimilar natalizumab” novartis.com ↗ |
| Filed relapsing-remitting multiple sclerosis 3 milestones | |||||
| Filed | US (FDA) | — | relapsing-remitting multiple sclerosis | 2022-07-25 | “FDA und EMA haben einen ergänzenden Zulassungsantrag (supplemental Biologics License Application, sBLA) bzw. Marktzulassungsantrag (Marketing Authorization Application, MAA)...” novartis.com ↗ “the US Food and Drug Administration (FDA) has accepted its biologics license application (BLA) for a proposed first-of-a-kind biosimilar natalizumab” sandoz.com ↗ “Biosimilar natalizumab FDA and EMA accepted sBLA/MAA for proposed first-of-a-kind multiple sclerosis biosimilar natalizumab.” novartis.com ↗ “La FDA et l’EMA ont accepté la demande de licence supplémentaire d’un biologique (sBLA/MAA) pour natalizumab” novartis.com ↗ |
| Filed | EU (EMA) | — | relapsing-remitting multiple sclerosis | 2022-07-14 | “FDA und EMA haben einen ergänzenden Zulassungsantrag (supplemental Biologics License Application, sBLA) bzw. Marktzulassungsantrag (Marketing Authorization Application, MAA)...” novartis.com ↗ “The European Medicines Agency (EMA) also accepted the marketing authorization application (MAA) for this proposed biosimilar natalizumab, as announced on July 15” novartis.com ↗ “The European Medicines Agency (EMA) also accepted the marketing authorization application (MAA) for this proposed biosimilar natalizumab, as announced on July 15” sandoz.com ↗ “A Marketing Approval Application (MAA) for the proposed biosimilar natalizumab was also accepted by the European Medicines Agency (EMA) on 14 July 2022.” polpharmabiologics.com ↗ “Biosimilar natalizumab FDA and EMA accepted sBLA/MAA for proposed first-of-a-kind multiple sclerosis biosimilar natalizumab.” novartis.com ↗ “Europejska Agencja Leków (European Medicines Agency – EMA) przyjęła wniosek (Marketing Authorization Application – MAA)” polpharmabiologics.com ↗ “La FDA et l’EMA ont accepté la demande de licence supplémentaire d’un biologique (sBLA/MAA) pour natalizumab” novartis.com ↗ |
| Filed | UK (MHRA) | — | relapsing-remitting multiple sclerosis | — | “a separate application for the use of biosimilar natalizumab in RRMS has been made to the Medicines and Healthcare Products Regulatory Agency (MHRA)” polpharmabiologics.com ↗ |
| Approved Indication not stated 7 milestones | |||||
| Label expansions (5) | US (FDA) | TYSABRI | — | 2006-06-05 – 2013-12-15 | fda.gov ↗ |
| Filed | EU (EMA) | TYSABRI | — | 2010-12-22 | “We’ve filed with U.S. and European regulators seeking approval to update the TYSABRI label with information about JCV antibody status” biogen.com ↗ |
| Filed | US (FDA) | TYSABRI | — | 2010-12-22 | “We’ve filed with U.S. and European regulators seeking approval to update the TYSABRI label with information about JCV antibody status” biogen.com ↗ “The sBLA was submitted in December 2010 to update the Prescribing Information for TYSABRI” biogen.com ↗ |
| Refused (EMA) | EU (EMA) | Natalizumab Elan Pharma | — | 2008-01-11 | europa.eu ↗ |
| Approved | EU (EMA) | Tysabri | — | 2006-06-27 | europa.eu ↗ |
| Approved | US (FDA) | TYSABRI | — | 2004-11-23 | fda.gov ↗ |
| Filed | Japan (PMDA) | TYSABRI | — | — | “Biogen Idec submitted a Biologics License Application (BLA) for the marketing approval of TYSABRI with the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan.” biogen.com ↗ |
Trials 56
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT00424788 | Jan → Oct 2007 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 15 trials | ||||||
| Phase 1 | NCT05618301 | Jul 2023 → Jun 2025 | sickle cell disease | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 1 | NCT03093064 | Apr 2017 → Jun 2023 | schizophrenia | King's College London | Completed | No outcome recorded |
| Phase 1 | NCT01884935 | Jul 2013 → Sep 2014 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 1 | NCT02483845 | May 2013 → Nov 2017 | inclusion body myositis | Phoenix Neurological Associates, LTD | Unknown | No outcome recorded |
| Phase 1 | NCT00559702 | Oct 2007 → Nov 2011 | relapsing-remitting multiple sclerosis, secondary progressive multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT03811886 | Dec 2024 → Dec 2025 | osteosarcoma | Case Comprehensive Cancer Center | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT00675428 | Sep 2008 → Dec 2009 | plasma cell myeloma | Biogen | Terminated | No outcome recorded Stop: Enrollment |
| Phase 214 trials · 4 missed | ||||||
| Phase 2 | NCT03283371 | Mar 2018 → Jan 2020 | focal epilepsy | Biogen | Completed | Missed primary |
| Phase 2 | NCT02133924 | Aug 2016 → Dec 2020 | acute graft versus host disease | John Levine | Completed | Missed primary |
| Phase 2 | NCT02730455 | Jul 2016 → Nov 2017 | ischemic stroke | Biogen | Completed | Missed primary |
| Phase 2 | NCT02176031 | Jan 2015 → Feb 2019 | acute graft versus host disease | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT02142192 | Dec 2014 → Jun 2015 | multiple sclerosis | Biogen | Terminated | No outcome recorded |
| Phase 2 | NCT01955707 | Jan 2014 → Feb 2015 | ischemic stroke | Biogen | Completed | Missed primary |
| Phase 2 | NCT01405820 | Aug 2011 → Apr 2014 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 2 | NCT01416155 | Oct 2010 → Dec 2014 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 2 | NCT01077466 | Mar 2010 → Jan 2012 | primary progressive multiple sclerosis, secondary progressive multiple sclerosis | Rigshospitalet, Denmark | Completed | No outcome recorded |
| Phase 2 | NCT00516893 | Oct 2006 → Oct 2007 | multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 2 | NCT00831649 | Sep 2004 → Feb 2005 | rheumatoid arthritis | Biogen | Terminated | No outcome recorded |
| Phase 2 | NCT00097760 | Jun 2003 → Mar 2004 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 2 | NCT00055367 | Apr 2002 → May 2004 | Crohn disease | Biogen | Completed | No outcome recorded |
| Phase 2 | NCT00055536 | Apr 2002 → Jul 2003 | Crohn disease | Biogen | Completed | No outcome recorded |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT01440101 | Nov 2010 → Aug 2012 | multiple sclerosis | Biogen | Completed | Met primary |
| Phase 313 trials · 4 met primary · 3 missed | ||||||
| Phase 3 | NCT05265728 | Apr 2022 → Jan 2024 | relapsing-remitting multiple sclerosis | Biogen | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT04115488 | Oct 2019 → Aug 2021 | relapsing-remitting multiple sclerosis | Polpharma Biologics S.A. | Completed | Met primary |
| Phase 3 | NCT03689972 | Nov 2018 → Jan 2023 | relapsing-remitting multiple sclerosis | Biogen | Completed | Missed primary |
| Phase 3 | NCT01416181 | Sep 2011 → Jul 2015 | secondary progressive multiple sclerosis | Biogen | Terminated | Missed primary |
| Phase 3 | NCT01058005 | Mar 2010 → Apr 2012 | relapsing-remitting multiple sclerosis | Biogen | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00306592 | Mar 2006 → Dec 2007 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 3 | NCT00297232 | Mar 2006 → Apr 2014 | relapsing-remitting multiple sclerosis | Biogen | Terminated | No outcome recorded |
| Phase 3 | NCT00078611 | Mar 2004 → Mar 2005 | Crohn disease | Biogen | Completed | No outcome recorded |
| Phase 3 | NCT00276172 | Dec 2003 → Oct 2005 | multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 3 | NCT00032786 | Mar 2002 → Mar 2004 | Crohn disease | Biogen | Completed | Missed primary |
| Phase 3 | NCT00030966 | Jan 2002 → Apr 2005 | relapsing-remitting multiple sclerosis | Biogen | Completed | Met primary |
| Phase 3 | NCT00032799 | Dec 2001 → Sep 2003 | Crohn disease | Biogen | Completed | Met primary |
| Phase 3 | NCT00027300 | Nov 2001 → Nov 2004 | relapsing-remitting multiple sclerosis | Biogen | Completed | Met primary |
| Phase 418 trials · 1 met primary | ||||||
| Phase 4 | NCT05532163 | Jan → Oct 2023 | relapsing-remitting multiple sclerosis | Biogen | Terminated | No outcome recorded |
| Phase 4 | NCT05177718 | Sep 2022 → Apr 2023 | multiple sclerosis | Vanderbilt University Medical Center | Terminated | No outcome recorded |
| Phase 4 | NCT04225312 | Feb 2020 → Mar 2025 | relapsing-remitting multiple sclerosis | Amsterdam UMC, location VUmc | Unknown | Met primary |
| Phase 4 | NCT04048577 | Jul 2019 → Nov 2021 | relapsing-remitting multiple sclerosis | Berkovich, Regina MD, PhD Inc. | Unknown | No outcome recorded |
| Phase 4 | NCT03535298 | Jan 2019 → Jul 2027 expected | relapsing-remitting multiple sclerosis | The Cleveland Clinic | Active not recruiting | No outcome recorded |
| Phase 4 | NCT03516526 | Nov 2016 → Jun 2019 | multiple sclerosis | Amsterdam UMC, location VUmc | Completed | No outcome recorded |
| Phase 4 | NCT03046251 | Aug 2015 → Dec 2023 | multiple sclerosis | State University of New York at Buffalo | Completed | No outcome recorded |
| Phase 4 | NCT02342704 | Nov 2014 → May 2016 | relapsing-remitting multiple sclerosis | Biogen | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT02241785 | Sep 2014 → May 2016 | multiple sclerosis | Biogen | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT02142205 | May 2012 → Dec 2013 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 4 | NCT01591551 | Mar 2012 → Aug 2013 | relapsing-remitting multiple sclerosis | Cornerstone Health Care, PA | Completed | No outcome recorded |
| Phase 4 | NCT00871780 | Aug 2009 → Jul 2012 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 4 | NCT00942214 | Jun 2009 → Feb 2011 | multiple sclerosis | University Hospital, Toulouse | Completed | No outcome recorded |
| Phase 4 | NCT00801125 | Dec 2008 → May 2010 | Crohn disease | Biogen | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00771043 | Nov 2008 → Aug 2009 | relapsing-remitting multiple sclerosis | Biogen | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT00744679 | Nov → Dec 2008 | multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 4 | NCT00536120 | Jan 2008 → Nov 2009 | multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 4 | NCT00280956 | Jul 2002 → Sep 2004 | Crohn disease | Biogen | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT01455220 | Jan 2011 → Oct 2014 | multiple sclerosis | University of South Florida | Completed | No outcome recorded |
| — | NCT01071512 | Apr 2010 → Jan 2016 | multiple sclerosis | University of Chicago | Completed | No outcome recorded |
| Comparator or background therapy8 trials | ||||||
| Phase 2 | NCT05418010 Comparator | Dec 2022 → Oct 2027 expected | multiple sclerosis | Queen Mary University of London | Recruiting | No outcome recorded |
| Phase 2 | NCT01071083 Comparator | Mar 2010 → Nov 2011 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 2 | NCT00273364 Comparator | Nov 2005 → Jan 2017 | multiple sclerosis | Northwestern University | Completed | No outcome recorded |
| Phase 2 | NCT00083759 Comparator | May 2004 → Feb 2005 | rheumatoid arthritis | Biogen | Terminated | No outcome recorded |
| Phase 3 | NCT04047628 Background | Aug 2020 → Oct 2026 expected | relapsing-remitting multiple sclerosis, secondary progressive multiple sclerosis | National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting | No outcome recorded |
| Phase 4 | NCT02769689 Background | Jun 2019 → Jun 2024 | multiple sclerosis | University Hospital, Clermont-Ferrand | Unknown | No outcome recorded |
| Phase 4 | NCT02325440 Background | Mar 2014 → Apr 2016 | relapsing-remitting multiple sclerosis | University Hospital Muenster | Unknown | No outcome recorded |
| Phase 4 | NCT01144052 Comparator | Jun 2010 → Nov 2011 | relapsing-remitting multiple sclerosis | Claudio Gobbi | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 69
| Date | Issuer | Release |
|---|---|---|
| 2025-11-24 | BioLineRx, Ltd. | Results BioLineRx Reports Third Quarter 2025 Financial Results and Provides Corporate Update biolinerx.com ↗
The 10-subject proof-of-concept study, which was conducted in collaboration with Washington University School of Medicine, demonstrated that motixafortide alone, and in combination with natalizumab, were found to be safe and well- tolerated. |
| 2024-11-25 | BioLineRx, Ltd. | Results BioLineRx Reports Third Quarter 2024 Financial Results and Provides Update on Transformation to Drive Shareholder Value biolinerx.com ↗ |
| 2024-11-05 | BioLineRx, Ltd. | Results BioLineRx Announces Oral Presentation on Data from Phase 1 Clinical Trial Evaluating Motixafortide for CD34+ Hematopoietic Stem Cell Mobilization for Gene Therapies in Sickle Cell Disease at ASH 2024 biolinerx.com ↗
Findings suggest motixafortide alone, and in combination with natalizumab, could support the collection of the large number of stem cells required by gene therapies for sickle cell disease within a single apheresis cycle |
| 2023-09-26 | Sandoz | Regulatory Sandoz receives European Commission approval for Tyruko® (natalizumab), first and only biosimilar for multiple sclerosis in Europe sandoz.com ↗
Sandoz, a global leader in generic and biosimilar medicines, today announced that the European Commission (EC) granted marketing authorization for the first and only biosimilar Tyruko® (natalizumab), developed by Polpharma Biologics. |
| 2023-09-26 | Novartis Pharmaceuticals | Regulatory Sandoz receives European Commission approval for Tyruko® (natalizumab), first and only biosimilar for multiple sclerosis in Europe novartis.com ↗
Sandoz, a global leader in generic and biosimilar medicines, today announced that the European Commission (EC) granted marketing authorization for the first and only biosimilar Tyruko ® (natalizumab), developed by Polpharma Biologics. |
| 2023-09-26 | Polpharma Biologics S.A. | Regulatory Polpharma Biologics announces approval of Europe’s first and only biosimilar for multiple sclerosis – Tyruko® (natalizumab) polpharmabiologics.com ↗
Polpharma Biologics, an international biotech company dedicated to the development and manufacturing of biosimilars, today announced that the European Commission (EC) has approved Tyruko ® (natalizumab) as the first and only biosimilar for relapsing forms of multiple sclerosis (MS) in Europe. |
| 2023-08-28 | Polpharma Biologics S.A. | Regulatory Polpharma Biologics announces FDA approval of Tyruko® – first and only approved biosimilar to Tysabri®* for relapsing forms of multiple sclerosis polpharmabiologics.com ↗
Polpharma Biologics, an international biotech company dedicated to the development and manufacture of biosimilars, announced today that the U.S. Food and Drug Administration (FDA) is the first regulatory body worldwide to approve the use of Tyruko ® (natalizumab-sztn) – a new biosimilar for the treatment of relapsing forms of multiple sclerosis (MS). |
| 2023-08-25 | Sandoz | Regulatory Sandoz receives FDA approval for Tyruko® (natalizumab-sztn), first and only FDA-approved biosimilar for relapsing forms of multiple sclerosis sandoz.com ↗
Sandoz, a global leader in generic and biosimilar medicines, today announced that the US Food and Drug Administration (FDA) has approved its biosimilar Tyruko® (natalizumab-sztn), developed by Polpharma Biologics. |
| 2023-08-25 | Novartis Pharmaceuticals | Regulatory Sandoz receives FDA approval for Tyruko® (natalizumab-sztn), first and only FDA-approved biosimilar for relapsing forms of multiple sclerosis novartis.com ↗
Tyruko is approved to treat all indications covered by the reference medicine and is the first and only FDA-approved biosimilar for relapsing forms of multiple sclerosis (MS). |
| 2023-07-24 | Sandoz | Regulatory Sandoz receives positive CHMP opinion for multiple sclerosis biosimilar natalizumab sandoz.com ↗ |
| 2023-07-24 | Novartis Pharmaceuticals | Regulatory Sandoz receives positive CHMP opinion for multiple sclerosis biosimilar natalizumab novartis.com ↗ |
| 2023-07-24 | Polpharma Biologics S.A. | Regulatory Polpharma Biologics announces first-of-a-kind multiple sclerosis biosimilar natalizumab receives positive CHMP opinion polpharmabiologics.com ↗
Polpharma Biologics, an international biotech company dedicated to the development and manufacturing of biosimilars, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), adopted a positive opinion regarding granting marketing authorization for natalizumab – a first-of-a-kind biosimilar for the treatment of multiple sclerosis. |
| 2022-10-26 | Biogen | Results New Data at ECTRIMS 2022 Highlight Biogen’s Commitment to Advancing Individualized Disease Management for People Living with MS biogen.com ↗
Patient-reported outcomes favored TYSABRI ® (natalizumab) compared to Ocrevus ® (ocrelizumab); new insights on subcutaneous administration one year after approval in Germany |
| 2022-10-25 | The Medicines Company | Regulatory Novartis maintient sa dynamique de croissance et confirme les prévisions de l’exercice 2022 pour le Groupe novartis.com ↗
La FDA et l’EMA ont accepté la demande de licence supplémentaire d’un biologique (sBLA/MAA) pour natalizumab, le premier biosimilaire de sa catégorie pour le traitement de la SEP. |
| 2022-07-29 | Polpharma Biologics S.A. | Regulatory Polpharma Biologics announces FDA file acceptance for review of natalizumab, first proposed biosimilar to Tysabri® polpharmabiologics.com ↗
Years of hard work on our proposed biosimilar of Tysabri ®* have culminated in this BLA submission that was accepted for review today by the U.S. FDA. |
| 2022-07-25 | Sandoz | Regulatory Applications for proposed first-of-a-kind multiple sclerosis biosimilar natalizumab accepted by US FDA and EMA sandoz.com ↗
Sandoz, a global leader in generic and biosimilar medicines, announced today that the US Food and Drug Administration (FDA) has accepted its biologics license application (BLA) for a proposed first-of-a-kind biosimilar natalizumab, developed by Polpharma Biologics. |
| 2022-07-25 | Novartis Pharmaceuticals | Regulatory Applications for proposed first-of-a-kind multiple sclerosis biosimilar natalizumab accepted by US FDA and EMA novartis.com ↗
Sandoz, a global leader in generic and biosimilar medicines, announced today that the US Food and Drug Administration (FDA) has accepted its biologics license application (BLA) for a proposed first-of-a-kind biosimilar natalizumab, developed by Polpharma Biologics. |
| 2022-07-20 | Polpharma Biologics S.A. | Regulatory Polpharma Biologics announces EMA acceptance of Marketing Authorization Application for proposed biosimilar natalizumab polpharmabiologics.com ↗
Przyjęcie wniosku przez EMA oznacza rozpoczęcie weryfikacji złożonej dokumentacji w celu wydania decyzji o dopuszczeniu leku do obrotu w krajach Unii Europejskiej. |
| 2022-04-04 | Biogen | Results New Data at AAN 2022 Highlight Real-World Evidence from Biogen’s MS Portfolio and Emerging Research on Disease Progression biogen.com ↗
Data from NOVA study further support the efficacy and safety of natalizumab IV when administered every six weeks as compared to the approved every four-week dosing |
| 2021-10-13 | Biogen | Results New MS PATHS Data at ECTRIMS 2021 Confirm Biogen’s Disease-Modifying Therapies Do Not Reduce Antibody Response to COVID-19 Vaccines in People with Multiple Sclerosis biogen.com ↗
MS PATHS data indicate that 100 percent of people with MS treated with natalizumab, interferons or fumarates achieved an antibody response following COVID-19 vaccination |
| 2021-10-13 | Biogen | Results New Data at ECTRIMS 2021 Highlight Biogen’s Focus on Patient-Centered Outcomes and Improving the MS Patient Experience biogen.com ↗
Full analysis of Phase 3b NOVA study provides insights on efficacy of every six-week dosing with natalizumab as compared to the approved every four-week dosing |
| 2021-08-02 | Biogen | Results Biogen Announces Results from Phase 3b NOVA Study Evaluating Every Six-Week Dosing with Natalizumab in Relapsing-Remitting Multiple Sclerosis biogen.com ↗
The primary endpoint showed a numerical difference between the mean number of new or newly enlarging T2 hyperintense lesions at week 72 of 0.05 (Q4W) and 0.20 (Q6W) (p=0.0755), which based on the full trial results is not clinically meaningful. |
| 2021-04-28 | Biogen | Regulatory Biogen Provides Regulatory Update on the Supplemental Biologic License Application (sBLA) for Subcutaneous Administration of TYSABRI® (natalizumab) biogen.com ↗
Biogen Inc. (Nasdaq: BIIB) today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its supplemental Biologic License Application (sBLA) for a new subcutaneous (SC) route of administration of TYSABRI® (natalizumab) to treat relapsing multiple sclerosis (MS). |
| 2021-04-16 | Biogen | Results New Data at AAN 2021 from Across Biogen’s MS Portfolio Demonstrate Positive Impact of Treatment on People Living with Relapsing Multiple Sclerosis biogen.com ↗
New findings from MS PATHS show that treatment with TYSABRI ® (natalizumab) can lead to meaningful improvements in mental and social health compared to Ocrevus ® (ocrelizumab) |
| 2021-04-07 | Biogen | Regulatory The European Commission Grants Marketing Authorization for New Subcutaneous Administration of TYSABRI® (natalizumab) to Treat Relapsing-Remitting Multiple Sclerosis biogen.com ↗
Biogen Inc. (Nasdaq: BIIB) today announced that the European Commission (EC) has granted marketing authorization for a subcutaneous (SC) injection of TYSABRI® (natalizumab) to treat relapsing-remitting multiple sclerosis (MS). |
| 2020-09-11 | Biogen | Results New Data at ACTRIMS-ECTRIMS Meeting Showcase Safety and Efficacy of Biogen’s Industry-Leading MS Portfolio biogen.com ↗ |
| 2020-05-19 | Biogen | Results New Data at AAN Showcase Biogen’s Commitment to Advancing Innovation in MS biogen.com ↗
In addition, an analysis of TYSABRI ® (natalizumab) contributes to data demonstrating the reduced risk of progressive multifocal leukoencephalopathy (PML) through extended interval dosing (EID; approximately every six weeks) as compared to the currently approved dosing of every four weeks. |
| 2019-09-12 | Biogen | Results New Research Demonstrate Biogen’s Continued Commitment to Improve Care of Patients with Multiple Sclerosis Across Treatment Spectrum biogen.com ↗
An analysis of data from the TYSABRI Observational Program (TOP) demonstrates real-world effectiveness of extended interval dosing (every six weeks) with natalizumab |
| 2019-09-11 | Biogen | Results New Data Presented at ECTRIMS Reinforce Long-term Benefits of TECFIDERA® (dimethyl fumarate) Over 10 Years biogen.com ↗
TECFIDERA demonstrated comparable effectiveness to fingolimod and was less effective than natalizumab and alemtuzumab. |
| 2019-05-07 | Biogen | Results Data at AAN Demonstrate Biogen’s Leadership and Commitment to Innovation in MS biogen.com ↗
Updated results support lower risk of PML with extended interval dosing (EID; approximately every six weeks) for TYSABRI ® (natalizumab) in patients in a real-world setting |
| 2019-05-01 | Biogen | Results Biogen To Present Data At AAN Highlighting Its Innovative Marketed Treatments And Investigational Pipeline Programs For Complex Neurodegenerative Diseases biogen.com ↗
Natalizumab Reduces Serum Concentrations of Neurofilament Light |
| 2018-10-11 | Biogen | Results Biogen Advances Research to Improve Outcomes for Patients With Multiple Sclerosis biogen.com ↗
Real-world data add to the large body of evidence establishing the long-term effectiveness of TECFIDERA and TYSABRI, including in newly diagnosed patients |
| 2018-10-02 | Biogen | Results Biogen Highlights at ECTRIMS 2018 Data on Its Industry-Leading Multiple Sclerosis Portfolio and a Range of Initiatives Aimed at Transforming Patient Care biogen.com ↗
Updated data from the TYSABRI Observational Program (TOP), the largest ongoing, real-world study of TYSABRI-treated patients, underscore the established and consistent effectiveness of TYSABRI over 10 years, especially for those patients earlier in their disease course. |
| 2018-02-07 | Biogen | Results Biogen Reports Top-Line Results from Phase 2b Study of Natalizumab in Acute Ischemic Stroke biogen.com ↗
Biogen (Nasdaq: BIIB) announced today that in the Phase 2b dose-ranging ACTION 2 study in individuals with acute ischemic stroke (AIS), natalizumab did not demonstrate improvement in clinical outcomes compared to placebo. |
| 2017-04-18 | Biogen | Results Biogen Highlights Advances from Its Neurology Research Programs and Portfolio of Innovative Medicines at AAN Congress biogen.com ↗
TECFIDERA ® and TYSABRI ® Data Support Early Treatment to Improve MS Patient Outcomes |
| 2016-05-31 | Biogen | Regulatory Biogen Receives Positive CHMP Opinion for TYSABRI® (Natalizumab) Use in Highly Active RRMS Patients with Inadequate Response to Prior MS Therapy biogen.com ↗
The Committee of Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of a variation to the marketing authorization of TYSABRI ® (natalizumab), Biogen (NASDAQ: BIIB) announced today. |
| 2015-10-21 | Biogen | Results Biogen Reports Top-Line Results from Phase 3 Study Evaluating Natalizumab in Secondary Progressive MS biogen.com ↗
The Phase 3 ASCEND study investigating natalizumab in the treatment of secondary progressive multiple sclerosis (SPMS) did not achieve its primary and secondary endpoints, Biogen (NASDAQ: BIIB) reported today. |
| 2015-10-01 | Biogen | Results Biogen to Highlight Broad Research Commitment to MS Care at ECTRIMS Congress, Including New TECFIDERA® Data Demonstrating Importance of Early Treatment biogen.com ↗
No Evidence of an Increased Risk for Malignancy Associated with Natalizumab Therapy in Nine Years of Postmarketing Surveillance |
| 2015-04-07 | Biogen | Results Biogen Data at AAN Annual Meeting Underscore Commitment to Advancing Patient Care in Neurology biogen.com ↗
Natalizumab-Treated Patients with Multiple Sclerosis Have Low Rates of Brain Volume Decrease and Low MRI Disease Activity in the Long-Term STRATA Study |
| 2014-05-01 | Biogen | Results New TYSABRI® Analysis at AAN Annual Meeting Shows Improved Walking Speed in Significant Number of MS Patients biogen.com ↗
TYSABRI was associated with a 20 percent increase in walking speed, a clinically relevant improvement, in a significantly greater number of patients compared to placebo. |
| 2014-04-14 | Biogen | Results Biogen Idec to Present New Clinical Data from Its Robust Neurology Portfolio at AAN Annual Meeting biogen.com ↗
TYSABRI Natalizumab Treatment Improves Walking Speed in MS Patients: A Post Hoc Analysis of AFFIRM |
| 2013-10-03 | Biogen | Results New TYSABRI® Data Show Earlier Treatment and Longer-Term Use Result in Significant Reductions in MS Disease Activity biogen.com ↗
Biogen Idec (NASDAQ: BIIB) today announced results from several new analyses of TYSABRI ® (natalizumab) data that demonstrate its effectiveness in reducing multiple sclerosis (MS) disease activity. |
| 2013-03-18 | Biogen | Results ADDING MULTIMEDIA New TYSABRI Data Reaffirm Substantial Efficacy in Treatment of People with MS and Demonstrate Stability of Anti-JCV Antibody Status biogen.com ↗
TYSABRI demonstrated a significantly lower rate of first relapse compared to interferon beta (IFN) and glatiramer acetate (GA). |
| 2013-01-16 | Biogen | Regulatory Biogen Idec and Elan Submit Applications for First-Line Use of TYSABRI in anti-JCV Antibody Negative Patients with MS biogen.com ↗
Today Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced that they have submitted applications to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) requesting updates to the TYSABRI ® (natalizumab) labels. |
| 2012-10-11 | Biogen | Results TYSABRI® (natalizumab) Data at ECTRIMS Reaffirm Positive Effects of Treatment for People with Relapsing Forms of MS biogen.com ↗
“These data further establish the benefits of TYSABRI in reducing relapse rates and slowing disease progression,” said Alfred Sandrock, M.D., Ph.D., senior vice president, Development Sciences and Chief Medical Officer, Biogen Idec. |
| 2012-10-10 | Biogen | Results Biogen Idec’s Commitment to MS Demonstrated Through Significant Scientific Data Being Presented at the 28th ECTRIMS biogen.com ↗
Improvement of MS-related fatigue also significantly improves quality of life in patients treated with natalizumab: results from the TYNERGY trial |
| 2012-05-17 | Biogen | Results New Analysis of Risk Stratification for TYSABRI® Published in New England Journal of Medicine biogen.com ↗
The analysis looked at three risk factors associated with a patient’s PML risk: anti-JC virus (JCV) antibody status, use of immunosuppressant (IS) therapy prior to TYSABRI initiation, and longer duration of treatment with TYSABRI. |
| 2012-04-26 | Biogen | Results New TYSABRI Data Presented at 64th Annual AAN Meeting Highlight Biogen Idec & Elan Commitment to Improving Outcomes in Multiple Sclerosis biogen.com ↗
Initial results from the TYSABRI Observational Program (TOP) indicate that post-baseline annualized relapse rates (ARR) after four years for patients receiving TYSABRI therapy decreased from 1.99 at baseline to 0.28 (p<0.0001); |
| 2012-01-20 | Biogen | Regulatory FDA Updates TYSABRI® (natalizumab) Label to Include Anti-JC Virus Antibody Status as a PML Risk Factor biogen.com ↗
Today Biogen Idec (NASDAQ: BIIB) and Elan Corporation , plc (NYSE: ELN) announced that the U.S. Food and Drug Administration (FDA) has approved a product label change for TYSABRI that will help enable individual benefit risk assessment for patients with multiple sclerosis (MS). |
| 2011-10-20 | Biogen | Regulatory Biogen Idec and Elan Receive Notification of PDUFA Date Extension biogen.com ↗
Today Biogen Idec (NASDAQ: BIIB) and Elan Corporation , plc (NYSE: ELN) announced that the U.S. Food and Drug Administration (FDA) has extended the initial PDUFA date for its review of the supplemental Biologics License Application (sBLA) for TYSABRI® (natalizumab). |
| 2011-10-19 | Biogen | Results Data about Early Use and Long-Term Benefit of TYSABRI Presented at 5th Joint Triennial Congress of ECTRIMS and ACTRIMS biogen.com ↗
Key data indicated patients on TYSABRI experienced reduced annualized relapse rates (ARR), particularly in those treated with TYSABRI early in the course of their disease. |
| 2011-06-22 | Biogen | Regulatory European Commission Approves Inclusion of Anti-JC Virus Antibody Status as a PML Risk Factor in TYSABRI Labeling biogen.com ↗
In addition, as part of a standard review process, the EC concluded the quality, safety and efficacy of TYSABRI continue to be adequately demonstrated and renewed the EU five-year Marketing Authorisation. |
| 2011-04-18 | Biogen | Regulatory CHMP Recommends Updating TYSABRI Labeling with anti-JC Virus Antibody Status as a Third Factor to Further Stratify Risk of PML biogen.com ↗
The CHMP has also adopted a positive opinion for the five year renewal of the Marketing Authorisation for TYSABRI. |
| 2010-12-22 | Biogen | Regulatory Biogen Idec and Elan Submit Applications to Update TYSABRI Labeling That May Help Stratify Risk of PML with Anti-JC Virus Antibody Status biogen.com ↗
The companies are proposing updated product labeling to include anti-JC Virus antibody status as one potential factor to help stratify the risk of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection, in the TYSABRI-treated population. |
| 2010-10-26 | Biogen | Results Biogen Idec Reports Third Quarter 2010 Results biogen.com ↗
Data presented at the 26th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) further supported the potential clinical utility of an investigational assay that detects anti-JC virus (JCV) antibodies in human plasma or serum. |
| 2010-10-16 | Biogen | Results Data Further Supporting Anti-JC Virus Antibody Assay Presented at the 26th Congress of the European Committee for Treatment and Research in Multiple Sclerosis biogen.com ↗
Biogen Idec (NASDAQ: BIIB) and Elan Corporation , plc (NYSE: ELN) today announced data further supporting the potential clinical utility of an investigational assay that detects anti-JC virus (JCV) antibodies in human plasma or serum. |
| 2010-08-24 | Biogen | Results Preliminary Data in Support of Investigational Anti-JCV Antibody Assay Published in the Annals of Neurology biogen.com ↗
These data showed that all 17 patients were anti-JCV antibody positive prior to the onset of PML. |
| 2010-04-13 | Biogen | Results Large Body of Data on TYSABRI® to Be Presented at Annual Meeting of the American Academy of Neurology biogen.com ↗
The presented data, based on post-hoc analyses and patient-reported outcomes studies, highlights the ability of TYSABRI (natalizumab), in some multiple sclerosis (MS) patients, to improve sustained visual function, disability, overall quality of life (QoL), cognition and fatigue. |
| 2009-10-27 | Biogen | Results Subset Data from Two Randomized Phase 3 Trials Show TYSABRI Significantly Reduces Rates of Hospitalization in Patients with Moderate-to-Severe Crohn’s Disease biogen.com ↗
Elan Corporation, plc (NYSE: ELN) and Biogen Idec (NASDAQ: BIIB) today announced data showing that treatment with TYSABRI ® (natalizumab) significantly reduced the rate of hospitalization compared with placebo in patients with moderate–to–severe Crohn’s disease during both induction and maintenance treatment. |
| 2009-09-11 | Biogen | Results Data Supporting Unique Efficacy of TYSABRI Presented at the 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis biogen.com ↗
TYSABRI significantly promoted remyelination when compared to patients treated with interferon beta-1a IM and healthy volunteers. |
| 2009-05-31 | Biogen | Results Subset Data from Two Randomized Phase 3 Trials Show TYSABRI® Significantly Improves Health-Related Quality of Life for Crohn’s Disease Patients with Prior Exposure or Inadequate Response to Anti-TNFα Therapy biogen.com ↗
Elan Corporation, plc (NYSE: ELN) and Biogen Idec (NASDAQ: BIIB) shared data today that TYSABRI ® (natalizumab) improved health related quality of life (QOL) in Crohn’s Disease (CD) patients who had previously been exposed to or failed anti-TNFα therapy versus placebo. |
| 2009-04-28 | Biogen | Results MRI Data Showing TYSABRI® Promoted Remyelination Presented at the 61st Annual Meeting of the American Academy of Neurology biogen.com ↗
The study showed that TYSABRI promoted remyelination when compared to those receiving interferon beta-1a IM and normal controls. |
| 2009-04-16 | Biogen | Regulatory Biogen Idec Receives Approval for TYSABRI® High Titer Production biogen.com ↗
Biogen Idec (NASDAQ: BIIB) today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s high titer process for the production of its multiple sclerosis (MS) drug TYSABRI ® (natalizumab). |
| 2009-02-09 | Biogen | Results MS Patients Treated with TYSABRI® Remain Free of Disease Activity for Two Years, According to Data Published in the Lancet Neurology biogen.com ↗
Results from this retrospective analysis showed that two years after beginning treatment with TYSABRI, 37 percent of patients remained free of disease activity, compared to seven percent of placebo-treated patients. |
| 2008-09-19 | Biogen | Results TYSABRI(R) Demonstrates Sustained Improvement in Functional Outcomes in Multiple Sclerosis Patients According to New Post-Hoc Analysis biogen.com ↗
Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced that a post-hoc analysis showed TYSABRI ® (natalizumab) treatment increases the probability of achieving sustained improvement in physical disability over two years when compared to placebo. |
| 2008-04-16 | Biogen | Results Data Presented at the 60th Annual Meeting of the American Academy of Neurology Offers Additional Support for Plasma Exchange as a Potential Tool to Accelerate TYSABRI(R) Removal biogen.com ↗
Based on the PLEX findings, plasma exchange was effective at accelerating the normal decline of TYSABRI serum concentrations. |
| 2008-04-15 | Biogen | Results Biogen Idec and Elan Present New TYSABRI(R) Data at the 60th Annual Meeting of the American Academy of Neurology biogen.com ↗
Using clinical and MRI disease-free criteria combined, a stringent definition of disease free, 36.7% and 31.7% of patients in the TYSABRI groups were disease free compared with 7.2% and 10.9% given placebo in the AFFIRM and SENTINEL trials, respectively. |
| 2008-01-14 | Biogen | Regulatory FDA Approves TYSABRI(R) for the Treatment of Moderate-to-Severe Crohn's Disease biogen.com ↗
Elan Corporation, plc (NYSE: ELN) and Biogen Idec (NASDAQ: BIIB) today announced the approval of a supplemental Biologics License Application (sBLA) by the U.S. Food and Drug Administration (FDA) for TYSABRI ® (natalizumab). |
| 2008-01-07 | Biogen | Results Biogen Idec and Elan Provide Update on Utilization, Safety and Total Patient Exposure of TYSABRI(R) in Patients with Multiple Sclerosis biogen.com ↗
Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) today announced new data on the global utilization, safety and overall patient exposure of TYSABRI ® (natalizumab). |
All press releases naming this drug 88 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 69 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Natalizumab | “Standard treatment with a conventional drug is the treatment with one of the following drugs: Avonex (interferon beta 1a), Betaseron (interferon beta 1b), Copaxone (glatiramer...” NCT00273364 ↗61“Natalizumab (Tyruko®) is a medication currently approved by the Medicines and Healthcare products Regulatory Agency (MHRA) as a disease-modifying treatment for adults with...” NCT05418010 ↗ “Natalizumab (TYSABRI®) or Interferon beta-1a (AVONEX®) treatments initiated at the time of acute optic neuritis (AON)” NCT00771043 ↗ “natalizumab (Tysabri®)” NCT04047628 ↗ “BG00002 (natalizumab)” NCT02142205 ↗ “Tysabri (natalizumab)” NCT03535298 ↗ |
| Known as | Antegren | “A Phase II, International, Multicenter, Open Label Study of the Safety, Tolerability and Effectiveness of Three Intravenous Infusions of Antegren (Natalizumab) in Adolescents...” NCT00055367 ↗4“A Phase 3 International, Multicenter, Double-blind, Placebo-controlled Study of the Safety, Efficacy, and Tolerability of Intravenous Antegren (Natalizumab) in Subjects With...” NCT00032799 ↗ “Intravenous Antegren (Natalizumab) in Crohn's Disease Subjects” NCT00055536 ↗ “Intravenous Antegren(TM) (Natalizumab)” NCT00078611 ↗ “Intravenous Antegren (Natalizumab)” NCT00032786 ↗ |
| Known as | BG00002 | “The primary objective of the study is to determine the efficacy of natalizumab (Tysabri, BG00002) in participants with relapsing forms of multiple sclerosis (MS) who have...” NCT02241785 ↗7“Biological: BG00002 (natalizumab)” NCT00306592 ↗ “Drug: BG00002 (natalizumab)” NCT00675428 ↗ “Natalizumab (BG00002)” NCT01440101 ↗ “BG00002 (natalizumab)” NCT01058005 ↗ “BG00002 (natalizumab)” NCT00871780 ↗ “BG00002 (natalizumab)” NCT00536120 ↗ “BG00002 (natalizumab)” NCT02142205 ↗ |
| Known as | NAT | “Leukocyte sequestration is an established therapeutic concept in multiple sclerosis (MS) as represented by the trafficking drugs natalizumab (NAT) and fingolimod (FTY).” PMID 30050529 ↗ Jul 2018 |
| Known as | natalizumab (Tysabri) | “natalizumab (Tysabri®)” NCT04047628 ↗ |
| Known as | NTZ | “Natalizumab (NTZ) a current treatment for MS can be used as a second line therapy” NCT00942214 ↗2“Natalizumab (NTZ) is a highly effective therapy for multiple sclerosis (MS)” PMID 40988462 ↗ Sep 2025 “Drug: natalizumab (NTZ)” NCT02769689 ↗ |
| Known as | Tyruko | “Natalizumab (Tyruko®) is a medication currently approved by the Medicines and Healthcare products Regulatory Agency (MHRA) as a disease-modifying treatment for adults with...” NCT05418010 ↗ |
| Known as | TYSABRI | “The primary objective of the study is to determine the efficacy of natalizumab (Tysabri, BG00002) in participants with relapsing forms of multiple sclerosis (MS) who have...” NCT02241785 ↗10“Standard treatment with a conventional drug is the treatment with one of the following drugs: Avonex (interferon beta 1a), Betaseron (interferon beta 1b), Copaxone (glatiramer...” NCT00273364 ↗ “In part 2, participants received natalizumab (Tysabri®) 300 mg via IV infusion Q6W for 36 weeks and then were randomized to 48 weeks of crossover treatment (24 weeks SC Q6W and...” PMID 39046635 ↗ Jul 2024 “All eligible patients will be randomly assigned to one of two treatment groups in a 1:1 ratio, to receive a total of twelve intravenous (IV) infusion of either PB006 or Tysabri...” NCT04115488 ↗ “Natalizumab (TYSABRI) is a protein-based drug that is manufactured by Biogen Idec in partnership with Elan Pharmaceuticals.” NCT00424788 ↗ “Natalizumab (Tysabri) therapy” NCT01591551 ↗ “Tysabri ® (Natalizumab)” NCT01455220 ↗ “TYSABRI® (natalizumab)” NCT00801125 ↗ “Tysabri® (natalizumab)” NCT00536120 ↗ |
| Known as | Tysabri (natalizumab) | “Tysabri (natalizumab)” NCT03535298 ↗ |
| Action | Inhibit | “Natalizumab is the first alpha4 integrin antagonist in a new class of selective adhesion-molecule inhibitors.” PMID 16510744 ↗ Mar 2006 |
| Modality | Monoclonal antibody | “Natalizumab, a humanized monoclonal antibody against alpha4 integrin” PMID 16267322 ↗ Nov 2005 |
| Route | Intravenous | “Natalizumab 300 mg IV infusion” NCT00027300 ↗ |