MARKETING AUTHORIZATION APPLICATION FOR LECANEMAB AS TREATMENT FOR EARLY ALZHEIMER'S DISEASE ACCEPTED BY EUROPEAN MEDICINES AGENCY

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[{"type":"text","content":"TOKYO and CAMBRIDGE, Mass., Jan. 26, 2023 /PRNewswire/ -- 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 European Medicines Agency (EMA) has accepted a marketing authorization application (MAA) for lecanemab (Brand Name in the U.S.: LEQEMBI™), an investigational anti-amyloid beta (Aβ) protofibril* antibody, for the treatment of early Alzheimer's disease (mild cognitive impairment due to Alzheimer's disease (AD) and mild AD dementia) with confirmed amyloid pathology, for review following a standard timeline.\n\n \n \n \n \n \n \n\n \nIn the U.S., lecanemab was granted accelerated approval as a treatment for AD by the U.S. Food and Drug Administration (FDA) on January 6, 2023. On the same day, Eisai submitted a Supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway based on the results from the Phase III Clarity AD confirmatory study. In Japan, Eisai submitted a marketing authorization application to the Pharmaceuticals and Medical Devices Agency (PMDA) on January 16, 2023. In China, Eisai has initiated submission of data for a BLA to the National Medical Products Administration (NMPA) of China in December 2022.\nEisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.\n* Protofibrils are large Aβ aggregated soluble species of 75-500 Kd.1,2\nContacts\nMEDIA CONTACT:\nEisai Co., Ltd.\nPublic Relations Department\nTEL: +81-(0)3-3817-5120\n \nEisai Europe, Ltd.\n(Europe, Australia, New Zealand and Russia)\nEMEA Communications Department\[email protected]\nTEL: +44-(0)7739-600-678\n \nINVESTOR CONTACT:\nEisai Co., Ltd.\nInvestor Relations Department\nTEL: +81-(0)3-3817-5122\nMEDIA CONTACT:\nBiogen Inc.\nNatacha Gassenbach \n+ 1-857-777-6573\[email protected]\n \nINVESTOR CONTACT:\nBiogen Inc.\nMike Hencke\n+ 1-781-464-2442\[email protected]\n[Notes to editors]1. About Lecanemab Lecanemab (Brand Name in the U.S.: LEQEMBI™) is the result of a strategic research alliance between Eisai and BioArctic. Lecanemab is a humanized immunoglobulin gamma 1 (IgG1) monoclon...

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