Eisai Initiates Rolling Submission To The U.S. Fda For Biologics License Application Of Lecanemab (BAN2401) For Early Alzheimer’s Disease Under The Accelerated Approval Pathway

TOKYO and CAMBRIDGE, Mass., Sept. 27, Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, "Biogen") today announced that Eisai has initiated a rolling submission to the U.S. Food and Drug Administration (FDA) of a Biologics License Application (BLA) for lecanemab (BAN2401), the company's investigational anti-amyloid beta (Aβ) protofibril antibody, for the treatment of early Alzheimer's disease (early AD). The BLA is being submitted under the accelerated approval pathway and is primarily based on clinical, biomarker and safety data from the Phase 2b clinical trial (Study …

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2021-09-28 03:30:00