Eisai and Biogen provided an update on the European Union’s regulatory review of lecanemab, a treatment for early-stage Alzheimer’s disease. The European Commission requested the Committee for Medicinal Products for Human Use (CHMP) to review recently available safety information on lecanemab and clarify risk mitigation measures. This review will occur at the CHMP’s February 2025 meeting.
This regulatory update is crucial for both the companies and individuals affected by Alzheimer’s. A potential delay or rejection of lecanemab in the EU would significantly impact access to this promising treatment for a devastating disease with limited therapeutic options. The outcome of the CHMP’s review will heavily influence market availability and patient access across the European Union. Furthermore, it holds implications for the broader Alzheimer’s landscape, as lecanemab represents one of the few disease-modifying therapies currently under advanced regulatory consideration.
The CHMP issued a positive opinion on lecanemab in November 2024, recommending its approval. However, subsequent safety data prompted the European Commission’s request for further review. Eisai and Biogen maintain that the lecanemab safety profile observed in post-market settings aligns with existing labels and does not reveal new safety concerns. They are confident that the available data sufficiently addresses the European Commission’s questions.
The February 2025 CHMP meeting will be pivotal for the future of lecanemab in the EU. A positive outcome, confirming the previous approval recommendation, would pave the way for patient access in European countries. Conversely, a negative decision could lead to further delays or even rejection, hindering progress in addressing the substantial unmet medical need in Alzheimer’s disease. The CHMP’s decision will influence not only the availability of lecanemab but also the overall momentum and direction of Alzheimer’s drug development.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
