FDA OKs Biogen Alzheimer's Drug Despite Evidence Issue

Law360 (June 7, 2021, 4:59 PM EDT) -- The U.S. Food and Drug Administration on Monday approved Biogen's Alzheimer's drug aducanumab, despite an advisory panel's call that the agency shouldn't be so quick to embrace the biotech company's claims that the drug is effective against Alzheimer's.

FDA Center for Drug Evaluation and Research head Patrizia Cavazzoni said in an announcement that Biogen's amyloid beta drug Aduhelm would be "the first novel therapy approved for Alzheimer's disease since 2003."

The FDA's move came after the agency's Peripheral and Central Nervous System Drugs Advisory Committee said in November that the FDA's earlier endorsement of data from Biogen about the effectiveness of...

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