Abstract
In a stunning reversal, Biogen says it will ask the US Food and Drug Administration to approve its Alzheimer’s disease treatment aducanumab. In March, the biotech firm pulled the plug on Phase III studies of the antibody, which breaks up amyloid-β plaques in the brain, after an independent review board said it was unlikely to offer any meaningful benefit to people with the neurodegenerative disorder. The review board made its recommendation based on data from 1,748 patients who had been on the drug for 18 months. After the trials were discontinued, Biogen and its development partner, Eisai, analyzed a larger data set—3,285 patients, 2,066 of whom had received the full 18-month treatment course—and saw an improvement in a subset taking the highest dose of the drug. Biogen discussed that new trend with the FDA and now expects to file for approval in early 2020. Investors, Alzheimer’s experts, and industry watchers
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