Biogen Asks FDA To Approve Aducanumab

Biogen announced on the 8th July that it had submitted a biologics license application to the U.S. Food and Drug Administration for aducanumab, a therapeutic antibody developed to clear amyloid plaques from the brain. The Cambridge, Massachusetts, biotech company, in partnership with Eisai Co. Ltd., Tokyo, has requested a priority review, which could mean an FDA decision within six months. If approved, this would be the first biologic, first anti-amyloid treatment—and the first new drug for Alzheimer’s disease in more than 16 years in the U.S., since Namenda was approved in 2003.

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