TOKYO and CAMBRIDGE, Mass., November 15, 2024 – 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 a positive opinion has been received from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending approval of the amyloid-beta (Aβ) monoclonal antibody lecanemab as a treatment of adult patients with a clinical diagnosis of mild cognitive impairment and mild dementia due to Alzheimer’s disease (Early Alzheimer’s disease)  who are apolipoprotein E ε4 (ApoE ε4)* non-carriers or heterozygotes with confirmed amyloid pathology.1 Eisai had requested a re-examination of the prior negative opinion adopted by the CHMP in July 2024.

东京和马萨诸塞州剑桥，2024年11月15日–卫材株式会社（总部：东京，首席执行官：Haruo Naito，“卫材”）和Biogen Inc.（纳斯达克：BIIB，公司总部：马萨诸塞州剑桥，首席执行官：Christopher A.Viehbacher，“Biogen”）今天宣布，欧洲药品管理局（EMA）人类使用药品委员会（CHMP）发表了积极意见，建议批准淀粉样蛋白β（Aβ）单克隆抗体lecanemab，用于治疗临床诊断为轻度认知障碍和轻度痴呆的载脂蛋白Eε4（早期阿尔茨海默病）成年患者ApoEε4）*非携带者或杂合子，已确诊淀粉样蛋白病理。卫材已要求重新检查CHMP于2024年7月采用的先前负面意见。

In accordance with European Medicines Agency regulatory process, the European Commission is expected to make a final decision on the marketing authorization application (MAA) of lecanemab based on the CHMP recommendation within 67 days of receipt of CHMP opinion.2  Lecanemab selectively binds to soluble Aβ aggregates (protofibrils**), as well as insoluble Aβ aggregates (fibrils) which are a major component of Aβ plaques in AD, thereby reducing both Aβ protofibrils and Aβ plaques in the brain.3,4,5 AD currently affects an estimated 6.9 million people in Europe,6 and this figure is expected to nearly double by 2050 as aging populations increase.7 AD progresses in stages that increase in severity over time, and each stage of the disease presents different challenges for those living with AD and their care partners.

根据欧洲药品管理局（European Medicines Agency）的监管程序，欧盟委员会预计将在收到CHMP意见后67天内根据CHMP建议对莱卡单抗的上市许可申请（MAA）做出最终决定。2莱卡单抗选择性结合可溶性aβ聚集体（原纤维**）以及不溶性aβ聚集体（原纤维），它们是AD中aβ斑块的主要成分，从而减少大脑中的aβ原纤维和aβ斑块。3,4,5 AD目前影响欧洲估计有690万人，6随着人口老龄化的增加，这一数字预计到2050年将翻一番。7 AD分阶段发展随着时间的推移，严重程度会增加，疾病的每个阶段对患有AD的患者及其护理伙伴都提出了不同的挑战。

There is a significant unmet need for new treatment options that slow down the progression of early AD and reduce the overall burden on peopl.

对于减缓早期AD进展并减轻人群总体负担的新治疗方案，存在大量未满足的需求。