Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced  an update on the ongoing regulatory review of the Marketing Authorization Application for lecanemab as treatment for early AD (mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD) in the European Union.

In November 2024, a positive opinion was received from the Committee for Medicinal Products for Human Use (CHMP) recommending approval of lecanemab. As part of its decision-making process, the European Commission (EC) has asked the CHMP to consider information on the safety of lecanemab that became available after the adoption of the CHMP opinion in November 2024 and whether this may require an update of the opinion, and to consider whether the wording of the risk minimization measures in the opinion is clear enough to ensure correct implementation. These will be discussed at the CHMP meeting in February 2025.

The safety profile of lecanemab reported in clinical practice in the United States, Japan and other countries after launch is consistent with that in the approved labels, and no new safety signals are identified. We believe that the EC’s requests can be addressed with existing information and will be evaluated by the CHMP because of the clear and sufficient information available. We will continue to work closely with the authorities toward approval in the EU.

We will continue to make every effort to deliver lecanemab to patients with early AD in EU countries as soon as possible.

Eisai serves as the lead for lecanemab’s development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.