Biogen (BIIB): EMA has adopted a negative opinion on MAA of Lecanemab for early Alzheimer’s disease
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Update on Regulatory Review of Lecanemab for Early Alzheimer’s Disease in the European Union
July 26, 2024 7:20 AM EDTTOKYO 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 Alzheimers disease (AD) and mild AD).1
We are extremely disappointed by the CHMPs negative... More
