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Pfizer/Serono Rebif superiority

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Pfizer and Serono add 48-week data from the EVIDENCE study to Rebif labeling, firms announce May 22. The head-to-head study showed that 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 Biogen's Avonex 30 mcg intramuscular once weekly. At 48 weeks, 62% of Rebif (interferon beta-1a) patients remained relapse-free versus 52% of Avonex (interferon beta-1a) patients. Rebif was approved March 7, 2002, despite Avonex' orphan exclusivity, based on an advantage in 24-week relapse data. FDA reviewers predicted Rebif's superiority would likely be maintained beyond 48 weeks (1Pharmaceutical Approvals Monthly April 1, 2002, p. 4). Biogen has a long-term comparative trial underway. The approval also covers storage of Rebif at room temperature "for up to 30 days"...

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Serono Rebif Efficacy Gain Over Avonex Likely To Persist Past 48 Weeks–FDA





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