Eisai and Biogen Announce CHMP Decision to Uphold November 2024 Approval Recommendation for Anti-Aβ Monoclonal Antibody Lecanemab (Brand Name: Leqembi®)1Based on the review results from the CHMP, the European Commission (EC) will restart the decision-making process for the marketing authorization of lecanemab.
In January 2025, the European Commission (EC) requested the European Medicines Agency (CHMP) to reconfirm, as part of its decision-making process, whether an update to the approval recommendation for lecanemab was necessary based on safety information obtained after the approval recommendation was adopted in November 2024. Additionally, it sought confirmation that the description of risk minimization measures in the approval recommendation was sufficiently clear. After review, the CHMP concluded that no update to the approval recommendation for lecanemab was required.
The number of patients with mild cognitive impairment (MCI) and Alzheimer's type dementia caused by Alzheimer's disease (AD) in Europe is estimated to be 15.2 million and 6.9 million, respectively.2. Alzheimer's disease (AD) gradually worsens over time. The progression of the disease not only imposes a significant burden on AD patients and their caregivers but also has a major impact on society as a whole. There is an urgent need for new treatment options that can slow the progression of AD from the early stages.
If the marketing authorization application for lecanemab is approved by the EC, the approval will apply to all 27 EU member states as well as Iceland, Liechtenstein, and Norway. Eisai and Biogen will continue to make every effort to provide lecanemab to early AD patients in Europe as soon as possible.
Eisai Co., Ltd. leads the global development and registration application of lecanemab, while the product is co-commercialized and promoted by Eisai Co., Ltd. and Biogen Inc. Among them, Eisai Co., Ltd. has the final decision-making authority.
References:
- Committee for Medicinal Products for Human Use. 2024. Leqembi (Lecanemab). Overview. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/leqembi#overview Last accessed:January 2025
- Gustavsson, A., et al. Global estimates on the number of persons across the Alzheimer’s disease continuum. Alzheimer’s & Dementia. 2023;19:658-670. https://alzjournals.onlinelibrary.wiley.com/doi/full/10.1002/alz.12694.
Number: ECN-2025-0019