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Eisai : FDA Accepts BLA And Grants Priority Review For Lecanemab To Treat Early Alzheimer's Disease

BioArctic AB's partner Eisai said that the U.S. Food and Drug Administration has accepted the Biologics License Application or BLA under the accelerated approval pathway for lecanemab, an investigational anti-amyloid beta (Aß) protofibril antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD, with confirmed presence of amyloid pathology in the brain.

Eisai's application has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) action date on January 6, 2023.

BioArctic stated that the acceptance of the BLA by the FDA entitles BioArctic to a milestone payment of 15 million euros from Eisai.

BioArctic noted that Eisai will submit for traditional approval of lecanemab to the FDA before the end of the first quarter 2023.

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