Update on Regulatory Review of Lecanemab for Early Alzheimer’s Disease in the European Union

Posted: July 29, 2024 at 2:33 am

TOKYO and CAMBRIDGE, Mass., July 26, 2024 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the Marketing Authorization Approval (MAA) for the humanized anti-soluble aggregated amyloid-beta (A?) monoclonal antibody lecanemab as treatment for early AD (mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD).1

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Update on Regulatory Review of Lecanemab for Early Alzheimer’s Disease in the European Union

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