EMA Accepts Aducanumab Marketing Authorization Application for Alzheimerís Disease

09 November 2020

GMP News

Biogen and Eisai announced that the European Medicines Agency (EMA) has confirmed it has accepted for review, following a standard timetable, the Marketing Authorization Application (MAA) for aducanumab, an investigational treatment for Alzheimer’s disease.

Clinical data from patients with Mild Cognitive Impairment due to Alzheimer’s disease and mild Alzheimer’s disease demonstrate that treatment with aducanumab resulted in the removal of amyloid beta and better clinical outcomes. If approved, aducanumab would become the first therapy to reduce the clinical decline in patients with Alzheimer’s disease.

“Alzheimer’s disease has become a significant and growing burden for societies around the world, and we believe aducanumab represents the first breakthrough that can change the course of this devastating disease,” said Michel Vounatsos, Chief Executive Officer at Biogen. “We are committed to working with regulatory authorities worldwide and we look forward to the European Medicines Agency’s review of this application.”

Aducanumab is also under review with the U.S. Food and Drug Administration with Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of March 7, 2021.




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