Serono Rebif Approval Is First Orphan Drug Challenge Based On Efficacy
Executive Summary
FDA's licensure of Serono's Rebif marks the first time the agency has overridden orphan drug exclusivity based on an efficacy endpoint, a March 7 1Office of Orphan Products Development memo outlining FDA's rationale for the approval states
You may also be interested in...
Biogen Idec Deal Uses GSK Model; Partnerships To Double Pipeline By 2010
Biogen and Idec are applying the GlaxoSmithKline model to the biotech world with their $6.8 bil. merger agreement
Biogen Idec Deal Uses GSK Model; Partnerships To Double Pipeline By 2010
Biogen and Idec are applying the GlaxoSmithKline model to the biotech world with their $6.8 bil. merger agreement
Pfizer/Serono Rebif labeling
Pfizer/Serono Rebif (interferon beta-1a) revised labeling includes head-to-head data versus Biogen's Avonex (interferon beta-1a) out to 48 weeks. Multiple sclerosis patients treated with subcutaneous Rebif 44 mcg three times weekly "were more likely to remain relapse-free at 24 and 48 weeks" than patients treated with intramuscular Avonex 30 mcg once weekly. Of patients on Rebif, 62% remained relapse-free over the 48-week trial compared to 52% of Avonex patients. Revised labeling also notes one report of injection site necrosis during 48 weeks of Rebif treatment. Rebif was approved based on 24-week relapse data (1"The Pink Sheet" March 11, 2002, p. 19)...