EMA Agrees to Review Biogen, Eisai Request for Aducanumab’s Approval

EMA Agrees to Review Biogen, Eisai Request for Aducanumab’s Approval
The European Medicines Agency (EMA) has agreed to review Biogen and Eisai's application requesting the approval of aducanumab (BIIB037) for the treatment of Alzheimer’s disease. The companies’ approval request — in the form of a marketing authorization application (MAA) — will be analyzed by the EMA following the usual review timetable for new medications, which can take up to 210 days. If approved, the investigational treatment will become the first therapy for Alzheimer’s that has the potential to lower patients’ clinical decline and alter the course of the 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,” Michel Vounatsos, CEO of Biogen, said in a press release. “We are committed to working with regulatory authorities worldwide and we look forward to the European Medicines Agency’s review of this application,” Vounatsos added. Developed by Biogen in collaboration with Eisai, aducanumab is a man-made antibody that is designed to bind to the toxic clumps of beta-amyloid protein that are thought to be the underlying cause of neurodegeneration in Alzheimer’s. Earlier this year, the companies
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