Biogen

This sponsor has funded 24 studies across 32 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
3976 Finalised EU RMP category 3 Biogen Idec Multiple Sclerosis Pregnancy Exposure Registry Yes Yes
6782 Finalised EU RMP category 3 A Multicenter, Global, Observational Study to Collect Information on Safety and to Document the Drug Utilization of Tecfidera™ (Dimethyl Fumarate)... Yes Yes
7193 Ongoing Not included in RMP German Tysabri-Data-Register (Tysabri-Register) No No
9336 Finalised EU RMP category 3 A Retrospective, Multi-Center, Observational Study to Assess the Effect of Tecfidera® Delayed-Release Capsules on Lymphocyte Subsets in Subjects with... Yes Yes
13054 Finalised EU RMP category 3 EPID Multiple Sclerosis Pregnancy study - Pregnancy outcomes in Multiple Sclerosis populations exposed and unexposed to interferon beta - a... Yes Yes
19800 Ongoing EU RMP category 3 An observational study utilising data from the US Tysabri TOUCH programme and select EU MS Registries to estimate the risk of progressive multifocal... No No
21013 Finalised Not included in RMP Subcutaneous Interferon beta therapy in multiple sclerosis patients and characterization of injection site reactions and flu-like symptoms under daily... No Yes
21305 Finalised EU RMP category 3 Claims Database Study of Utilization Patterns of Dimethyl Fumarate in Germany Yes Yes
27459 Finalised Not included in RMP Plegridy™ (peginterferon β 1a) Real World Effectiveness and Safety Observational Program (POP) Yes Yes
28367 Finalised EU RMP category 3 A Multicenter, Multinational, Observational Study to Collect Information on Safety and to Document the Drug Utilization of Fampyra® When Used In... Yes Yes
28580 Ongoing EU RMP category 3 TOP: Tysabri® Observational Program No No
28904 Finalised Non-EU RMP-only TyPed - Natalizumab for the treatment of pediatric-onset multiple sclerosis in Portugal Yes Yes
28923 Finalised EU RMP category 3 JCV Antibody Program in Patients with Relapsing Multiple Sclerosis Receiving or Considering Treatment with Tysabri: STRATIFY-2 Yes Yes
28992 Finalised Non-EU RMP-only A Multicenter, Open-Label Safety Study of Natalizumab administered to Subjects with Relapsing Forms of Multiple Sclerosis who participated in STRATA Yes Yes
32033 Planned Not included in RMP Metabolic Profiling of Neuromuscular Diseases (MetabNMD) – subproject SMA No No
38347 Finalised Non-EU RMP-only Non-interventional Safety Study to Investigate Pregnancy Outcomes in Female Patients Exposed to SC Peginterferon Beta-1a and IM Interferon Beta-1a... Yes Yes
39505 Ongoing Non-EU RMP-only A Retrospective Analysis in Real World on Lymphocyte Reconstitution After Lymphopenia in Patients Treated by Tecfidera and Description of Management... No No
43860 Finalised Not included in RMP Incidence of Aicardi-Goutières syndrome (AGS) and KCNT1-related epilepsy in Denmark Yes Yes
44059 Ongoing Not included in RMP OPTIMISE:MS A Prospective, Real World Pharmacovigilance Study in Multiple Sclerosis Yes No
45445 Ongoing Non-EU RMP-only Long-term surveillance of patients with multiple sclerosis to report progressive multifocal leukoencephalopathy and other serious opportunistic... No No
48753 Ongoing EU RMP category 3 An Observational Study Utilising Data from EU National MS Registries to Estimate the Incidence of Anti-Natalizumab Antibody Among Patients Who Receive... No No
104368 Planned Non-EU RMP-only Spinraza (nusinersen) SMA Pregnancy Exposure Study Within Existing SMA Registries No No
106453 Planned EU RMP category 3 Vumerity (Diroximel Fumarate) Prospective MS Pregnancy Exposure Registry No No
106690 Finalised EU RMP category 3 An Observational, Cross-Sectional Survey to Assess PML Risk Awareness and Understanding from Patients’ Perspective and Effectiveness of the Tysabri... Yes No

PAS by Risk Management Plan (RMP) requirement

Biogen

The RMP for a medical product outlines strategies to identify, assess, and mitigate risks, including PAS for further evaluation.

Category 1 studies are imposed as condition of marketing authorisation.
Category 2 studies are imposed as specific obligation of marketing authorisation.
Category 3 studies are required under other circumstances.