Background
On 27 March 2025, the CHMP issued a negative opinion on donanemab, for the treatment of early symptomatic AD. In their decision, the CHMP cited an unfavourable benefit-risk balance: although donanemab slowed clinical decline over the 76-week study period, amyloid-related imaging abnormalities (ARIA) occurred in 36.8% of treated participants, compared to 14.9% of those receiving placebo. Consequently, the CHMP concluded that, even in a restricted population, the benefits did not outweigh the risks of serious adverse events.
Following the refusal, Eli Lilly requested a re-examination of the negative opinion for donanemab. Re-examination started on 2 June 2025 and the CHMP now has 60 days to re-examine its opinion, with a final outcome expected by the end of July.
Response
Alzheimer Europe regrets this negative opinion by the CHMP. People living with Alzheimer’s disease and their families had welcomed the positive opinion on lecanemab in November 2024 and had similar hopes about the introduction of an additional treatment for patients in Europe. The CHMP recommendation means that Europeans with early Alzheimer’s disease may not have access to an additional anti-amyloid treatment which is available to patients in many other countries and regions.
This position statement, issued in response to the CHMP opinion, identifies five key areas of concern for the European dementia community:
1. Refusal of donanemab risks creating disparities and worsening health inequalities
2. Approval of donanemab would support patient autonomy and provide choice for clinicians, patients and families
3. Targeted risk management strategies could enhance the benefit-risk profile of donanemab
4. Donanemab treatment can provide meaningful benefits to patients with early AD
5. Approval of donanemab could drive healthcare systems investment and maintain European competitiveness in R&D
Alzheimer Europe's full position can be downloaded below.