Biogen, Eisai Seek FDA Approval of Aducanumab for Alzheimer’s

Biogen, Eisai Seek FDA Approval of Aducanumab for Alzheimer’s
Biogen and Eisai have submitted a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) requesting the approval of aducanumab (BIIB037) for the treatment of Alzheimer’s disease. The submission, which was asking for priority review, had been pushed back earlier this year. The agency now has 60 days to decide whether to accept the BLA for review, and if accepted, whether it will be carried out under the FDA's priority review program. If approved, aducanumab will become the first therapy with the potential to slow the clinical decline seen in patients with Alzheimer’s, as well as the first to demonstrate that reducing the buildup of amyloid plaques in the brain of patients may lead to better outcomes. "The aducanumab BLA is the first filing for FDA approval of a treatment that addresses the clinical declin
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