FDA Committee Votes Do Not Support Aducanumab as Effective Treatment

FDA Committee Votes Do Not Support Aducanumab as Effective Treatment
An advisory arm of the U.S. Food and Drug Administration (FDA) is recommending that available clinical data on aducanumab (BIIB037) does not support the effectiveness of this investigational therapy in treating Alzheimer's disease.   In votes, eight of the committee's 11 members found Phase 3 EMERGE data did not provide "strong evidence" of efficacy, and seven members did not agree that aducanumab's initial PRIME study, a Phase 1b trial, showed evidence supporting effectiveness (the other four members cast "uncertain" votes), according to a press release. FDA Advisory Committees provide non-binding recommendations to the regulatory agency for consideration. FDA officials will now continue to review the biologics license application for aducanumab, with a final decision expected by March 7, 2021. Aducanumab, being developed by Biogen in collaboration with Eisai, is an antibody designed to clear toxic clumps of beta-amyloid protein, which are thought to damage the brain in people with Alzheimer's. Biogen has sponsored two Phase 3 clinical trials testing aducanumab in people with early Alzheime
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