Aducanumab Wins FDA Priority Review, Moves Closer to US Approval

Aducanumab Wins FDA Priority Review, Moves Closer to US Approval
The U.S. Food and Drug Administration (FDA) has accepted and given priority review designation to Biogen's application requesting the approval of aducanumab (BIIB037) for the treatment of Alzheimer’s disease. While the Prescription Drug User Fee Act (PDUFA) action date is set for March 7, 2021 — meaning a decision is due by then — the agency said it plans to act early on this application under an expedited review. An advisory committee meeting is in the FDA's plans for discussing this application, though no date has yet been set. The supplemental biologics license application (BLA) was based on data from two Phase 3 trials — EMERGE (NCT02484547) and ENGAGE (NCT02477800) — and from the Phase 1b PRIME trial (NCT01677572). That data demonstrated that aducanumab significantly slows cognitive decline and helps patients live an independent life for longer periods. If approved, aducanum
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