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

Core Viewpoint - Eisai Co., Ltd. and Biogen Inc. are progressing with the regulatory review of lecanemab for early Alzheimer's disease treatment in the European Union, following a positive recommendation from the CHMP in November 2024 [1][2]. Group 1: Regulatory Update - The European Commission has requested the CHMP to review new safety information regarding lecanemab that emerged after the initial recommendation, which will be discussed in February 2025 [2]. - The safety profile of lecanemab remains consistent with approved labels, with no new safety signals identified, indicating confidence in addressing the EC's requests with existing data [3]. Group 2: Product Development and Commercialization - Eisai leads the global development and regulatory submissions for lecanemab, with both Eisai and Biogen co-commercializing the product, while Eisai retains final decision-making authority [4][10]. - Lecanemab has received approvals in multiple countries, including the U.S., Japan, and China, and is currently under review in 17 countries, including the EU [7]. Group 3: Clinical Studies - Ongoing Phase 3 clinical studies, such as AHEAD 3-45 and Tau NexGen, are exploring lecanemab's efficacy in different stages of Alzheimer's disease, supported by public-private partnerships [9].