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

Core Viewpoint - Eisai and Biogen announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a negative opinion on the Marketing Authorization Approval for lecanemab, an anti-amyloid beta monoclonal antibody for early Alzheimer's disease treatment, which is a setback for the companies and the Alzheimer's community [1][2]. Company Overview - Eisai Co., Ltd. is headquartered in Tokyo and led by CEO Haruo Naito, while Biogen Inc. is based in Cambridge, Massachusetts, with CEO Christopher A. Viehbacher [1][2]. - Eisai is the lead developer for lecanemab, with both companies co-commercializing and promoting the product, and Eisai holding final decision-making authority [2][6]. Product Information - Lecanemab is already approved in several countries, including the U.S., Japan, China, South Korea, Hong Kong, and Israel, and is marketed in the U.S., Japan, and China [2][5]. - The drug targets early Alzheimer's disease, specifically mild cognitive impairment due to Alzheimer's disease and mild Alzheimer's disease [1][5]. - In clinical trials, lecanemab demonstrated a 27% reduction in clinical decline on the Clinical Dementia Rating Sum of Boxes (CDR-SB) scale at 18 months compared to placebo [5]. Market Context - Alzheimer's disease currently affects approximately 6.9 million people in Europe, with projections indicating this number could nearly double by 2050 due to aging populations [2][10]. - There is a significant unmet need for innovative treatment options targeting the underlying causes of Alzheimer's disease progression [1][5]. Regulatory Efforts - Eisai plans to seek re-examination of the CHMP's negative opinion and will collaborate with relevant authorities to make lecanemab available in the European Union as soon as possible [1][5]. - Applications for lecanemab's approval have been submitted in 12 countries and regions, including the EU [5].