Pfizer/Serono Rebif labeling

Executive Summary

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)...