FDA Advisory Panel Fails To Certify Effectiveness Of Biogen’s New Alzheimer’s Disease Drug

On November 6, 2020, the 11-person U.S. Food and Drug Administration (FDA) Peripheral and Central Nervous System Drugs Advisory Committee failed to certify the effectiveness of Biogen’s new drug, Aducanumab (BIIB037), as a treatment for Alzheimer’s disease. Voting was based on the results of the EMERGE and ENGAGE Phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel-group studies designed to evaluate the efficacy and safety of aducanumab. Voting was also based on the results of PRIME, a Phase 1b randomized, multicenter study that included a 12-month, double-blind, placebo-controlled period followed by a . . .