- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Biogen's (NASDAQ:BIIB) TYSABRI (natalizumab) for use as disease modifying therapy (DMT) for relapsing-remitting multiple sclerosis (RRMS) patients with highly active disease activity despite a full and adequate course of treatment with at least one DMT.
- The data supporting the company's application, called a type-II variation, was generated in a 10-year prospective real-study study called TOP (TYSABRI Observational Program).
- A final decision from the European Commission usually takes ~60 days.