CHMP Reaffirms Positive Opinion for Lecanemab in Early Alzheimer's Disease in EU

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has reaffirmed its positive opinion for the anti-amyloid monoclonal antibody lecanemab (Leqembi®), intended for the treatment of early Alzheimer's disease in apolipoprotein E ε4 (ApoE ε4) non-carriers or heterozygotes. This decision, announced on February 28, 2025, follows a review of additional safety information requested by the European Commission (EC) in January 2025.

Lecanemab, developed by Eisai and Biogen, has shown promising results in clinical trials, demonstrating a reduced progression of cognitive and functional deficits associated with Alzheimer's disease. The most common side effects are amyloid-related imaging abnormalities (ARIA), which can be managed with appropriate monitoring and risk minimization measures.

The CHMP's reaffirmation of its positive opinion for lecanemab is a significant milestone in the drug's regulatory journey in the EU. If approved by the European Commission, lecanemab will be available in all 27 European Union member states, as well as Iceland, Liechtenstein, and Norway. This approval will provide patients with another treatment option for early Alzheimer's disease, potentially improving patient outcomes and quality of life.



The CHMP's decision not to update its positive opinion for lecanemab, despite additional safety information requested by the EC, maintains the competitive landscape in the EU market for Alzheimer's disease treatments. Lecanemab's reaffirmed positive opinion means it remains on track for approval in the EU, providing patients with another treatment option alongside aducanumab (Aduhelm), which is already approved in the EU.

Lecanemab's less frequent intravenous maintenance dosing, approved by the FDA in January 2025, offers an alternative to Aduhelm's monthly infusions. This could make Leqembi more appealing to some patients and healthcare providers, as it may reduce the burden of frequent hospital visits. Additionally, Eisai is developing a subcutaneous auto-injection formulation for Leqembi, which could further enhance convenience and potentially increase its market share.

In conclusion, the CHMP's reaffirmation of its positive opinion for lecanemab in early Alzheimer's disease in the EU is a significant step towards expanding treatment options for patients. The competitive landscape in the EU market for Alzheimer's disease treatments remains dynamic, with Lecanemab and Aduhelm offering distinct advantages in terms of dosing, efficacy, and safety. As the regulatory process continues, patients and healthcare providers will benefit from the availability of multiple treatment options, ultimately driving market dynamics and improving patient outcomes.