28/03/2025
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a negative opinion on donanemab, for the treatment of early ’s disease. In its opinion, the CHMP highlighted safety concerns, noting that the benefits of donanemab were not large enough to outweigh the risk of potentially fatal events due to ARIA (amyloid-related imaging abnormalities).
This decision will come as a disappointment to people living with Alzheimer’s disease in Europe, who had hoped for the authorisation of an additional disease-modifying therapy.
Alzheimer Europe welcomes the attention the CHMP pays to patient safety, and was encouraged by the considered approach taken during the evaluation of lecanemab, which aimed to identify patients likely to benefit from treatment whilst excluding those at greatest risk of harmful side-effects. The organisation had hoped that a similar approach would be used for the evaluation of donanemab with a controlled access programme, rigorous safety monitoring requirements and the obligation for the company to conduct a post-authorisation safety study. This was the route chosen by regulators in the US, UK, China and Japan, where donanemab has been authorised.
Alzheimer Europe hopes that findings from real-world studies and ongoing trials of donanemab will provide the necessary scientific evidence for the EMA to reconsider its position.
https://www.alzheimer-europe.org/news/alzheimer-europe-regrets-negative-european-medicines-agency-opinion-donanemab-reduces-choice?language_content_entity=en