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FDA Accepted Eisai-Biogen’s Supplemental Biologics License Application For Leqembi (Lecanemab-IRMB) 100 mg/ml Injection For Intravenous Use, Supporting The Conversion Of The Accelerated Approval Of Leqembi To A Traditional Approval

The LEQEMBI application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of July 6, 2023. The FDA is currently planning to hold an Advisory Committee to discuss this application

BIIB