Biogen announced on the 8th July that it had submitted a biologics license application to the U.S. Food and Drug Administration for aducanumab [1], 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.
To read the full article visit the Alzforum website here. [2]