Alzheimer Europe regrets that negative European Medicines Agency opinion on donanemab reduces choice for Europeans with Alzheimer's disease

• The Committee for Medicinal Products for Human use (CHMP) of the European Medicines Agency (EMA) today issued a negative opinion on the marketing authorisation application of Eli Lilly for donanemab for slowing the progression of Alzheimer’s disease.
• Donanemab has already been approved by regulatory authorities in China, Japan, the United Kingdom (UK) and the United States (US).
• Lecanemab, another anti-amyloid therapy, received a positive opinion from the CHMP in November 2024 and is currently awaiting its marketing authorisation by the European Commission. Lecanemab has been approved by regulatory authorities in China, Hong Kong, Israel, Japan, Mexico, South Korea, the United Arab Emirates, the UK and the US.
• Alzheimer Europe therefore regrets the negative CHMP opinion, which means that Europeans with early Alzheimer’s disease may not have access to an additional treatment option available to patients in other countries.
• Alzheimer Europe fully supports the CHMP focus on patient safety, but feels that a controlled access programme and strict safety monitoring would have allowed access for Europeans to this treatment whilst excluding those most at risk of serious side effects.
• Alzheimer Europe hopes that real-world findings and data from ongoing trials of donanemab will provide the necessary scientific evidence for the EMA to reconsider its position.
  

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28 March 2025, Luxembourg - Today, the Committee for Medicinal Products for Human use (CHMP) of the European Medicines Agency (EMA) issued a negative opinion on the marketing authorisation application of Eli Lilly for donanemab for slowing disease progression in people with Alzheimer’s disease. In its opinion, the CHMP found that the benefits of treatment were not large enough to outweigh the risks associated with donanemab.

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 US Food and Drug Administration (FDA) granted traditional approval to donanemab in July 2024, with endorsement of its clinical efficacy by an advisory committee. In 2024, Donanemab was also approved for treatment of early Alzheimer’s disease by regulatory authorities in the United Kingdom (23 October), Japan (24 September) and China (17 December). The CHMP opinion is at odds with the decisions by regulatory authorities in these countries.

Alzheimer Europe supports the independent assessment of medicines across regions and highly values the EMA's scientific rigour. However, it is difficult to understand the CHMP’s negative opinion on a drug which has been approved by other regulators based on the same scientific evidence. Clinical experience in Japan and the US also shows that it is possible to safely administer anti-amyloid drugs in the real-world setting.  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 a number of other countries.

In its opinion, the CHMP highlighted the rates of ARIA (Amyloid-related Imaging Abnormalities), a side effect linked to small bleeds and areas of swelling in the brain. 1.6% of participants receiving donanemab experienced serious ARIA events, with three fatalities. People who carry no copies of ApoEε4, a genetic risk factor for ARIA, were at reduced risk of serious side effects (0.8%), with one fatality occurring.

Alzheimer Europe welcomes the attention the CHMP pays to patient safety when evaluating new medicines. The organisation was encouraged by the considered approach that the EMA took for its evaluation of lecanemab, which aimed to identify patients likely to benefit from treatment whilst excluding those at greatest risk of harmful side-effects. Alzheimer Europe 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 other regulators which approved donanemab. The FDA included a black box warning of ARIA in the prescribing information for the drug, stating that genetic testing for ApoEε4 should be performed prior to initiating treatment. The UK Medicines and Healthcare products Regulatory Agency (MHRA) similarly adopted measures to ensure patient safety, excluding individuals with two ApoEε4 copies, and mandating education and awareness programmes to minimise risk. 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.

Jean Georges, the Executive Director of Alzheimer Europe stated:

“It is unfortunate that people with Alzheimer’s disease in Europe will now be excluded from access to donanemab, without the possibility to make individual choices with their treating physicians, based on an analysis of the risks and benefits for different anti-amyloid treatments. As with medicines for other conditions, we should aim to have controlled access programmes for new treatments allowing patient choice whilst safeguarding against risks.”

You can find details of the CHMP recommendation here and the Eli Lilly statement here.