Update on regulatory review of lecanemab for early Alzheimer’s disease by the European Commission - Eisai

Eisai Co., Ltd. and Biogen Inc. announced an update on the ongoing regulatory review of the Marketing Authorization Application for lecanemab as a treatment for early AD (mild cognitive impairment and mild dementia due to Alzheimer’s disease (AD) by the European Commission (EC). The final process for the EC decision on lecanemab’s Marketing Authorisation Application (MAA) is underway, following the reconfirmation of the positive opinion for lecanemab’s approval by the Committee for Medicinal Products for Human Use (CHMP) in February 2025. Following the EC deliberations on the MAA in its Standing Committee in March 2025, the Appeal Committee has conducted its deliberations and did not reach a decision. In accordance with the legislation, the final decision regarding this MAA will be taken by the EC. Eisai will promptly disclose the final decision by the EC as soon as it is announced.