28 mar. 2025
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended against approving Eli Lilly's Alzheimer's treatment, Kisunla (donanemab), citing concerns that its benefits do not outweigh the risks of potentially fatal brain swelling and bleeding, known as amyloid-related imaging abnormalities (ARIA).
Clinical Trial Data:
ARIA occurred in 36.8% of patients treated with Kisunla, compared to 14.9% in the placebo group. Serious ARIA events were observed in 1.6% of patients, resulting in three deaths.
Flashback on LEQEMBI® (lecanemab):
July 2023: Alzheimer's treatment by Biogen and Eisai, LEQEMBI®, was approved by the US Food and Drug Administration
June 2024: LEQEMBI® failed to secure a recommendation for approval from CHMP.
November 2024: CHMP reversed course and backed approval for LEQEMBI®, but only in patients with one or no copies of the ApoE4 gene, after the request for re-examination.
January 2025: The European Commission asked CHMP to reconsider marketing recommendations upon new safety data, however, CHMP stayed strong on its decision.
Kisunla Timeline:
July 2024: Kisunla received FDA approval in the U.S.
October 2024: Lilly's Phase IIIb data showing that while it could not eliminate the adverse event, modified dosing regimens could lower the rates of ARIA and brain swelling.
The CHMP's decision underscores the ongoing challenges in balancing the potential benefits and risks of new Alzheimer's treatments. As the global population ages, the demand for effective therapies remains critical, emphasizing the need for continued research and dialogue among regulatory agencies, pharmaceutical companies, and the medical community.