FDA Extends Its Aducanumab Review with Decision Expected in June

FDA Extends Its Aducanumab Review with Decision Expected in June

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FDA Extends Its Aducanumab Review with Decision Expected in June

The U.S. Food and Drug Administration (FDA) has extended its review period for aducanumab (BIIB037), an investigational therapy for Alzheimer’s disease being co-developed by Biogen and Eisai. The three-month extension means the new deadline to review the compound’s biologics license application (BLA), also known as the Prescription Drug User Fee Act action date, is June 7, 2021. “We are committed to working with the FDA as it completes its review of the aducanumab application,” Michel…

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