Luxembourg, 25 July 2025 – Today, following a re-examination of its initial, negative opinion, the Committee for Medicinal Products for Human use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion on Lilly’s marketing authorisation application for donanemab for the treatment of early Alzheimer’s disease (mild cognitive impairment and mild dementia due to Alzheimer's disease).
In its opinion, the CHMP found that the benefits of donanemab for a restricted population outweighed its risks and therefore recommended approving the marketing authorisation application.
Alzheimer Europe welcomes the positive opinion by the CHMP, which follows that of other regulators. Donanemab had previously been approved by the US Food and Drug Administration (FDA) in July 2024, as well as by regulatory agencies in the United Arab Emirates (March 2024), Qatar (October 2024), Japan (October 2024), United Kingdom (October 2024), China (December 2024), Bahrain (December 2024), Mexico (January 2025), Kuwait (January 2025), Singapore (March 2025), Taiwan (April 2025), Brazil (April 2025) and Australia (May 2025).
The CHMP opinion also addresses many of the concerns highlighted in Alzheimer Europe’s official response to the initial CHMP decision, enabling patients to discuss treatment options and make informed choices based on their individual circumstances, preferences and values, including to the acceptability of risks and benefits.
In particular, Alzheimer Europe highlighted the risks associated with amyloid-related imaging abnormalities (ARIA) which can present as small bleeds in the brain or oedema.The organisation therefore appreciates and supports the careful approach that the EMA has taken to identify patients likely to benefit from treatment and to exclude those at greatest risk of harmful side-effects, such as people with two copies of the ApoE4 gene.
During the re-examination, the CHMP also considered data on a modified titration regimen for donanemab. In this modified regime, the dose of the drug is gradually increased over the four first infusions, compared to the original regime in which a lower dose is provided during the first three infusions, then stepped up for the fourth infusion. Data from the TRAILBLAZER-ALZ6 study showed that this small change led to a 41% reduction in relative risk of ARIA.
The CHMP has also mandated additional measures to reduce risk, including a controlled access programme and regular MRI scans for safety monitoring. The opinion states that donanemab should be administered under the supervision of a clinical team trained in detection, monitoring and management of ARIA, with experience in detecting and managing infusion-related reactions. The company will also establish an EU-wide registry study to monitor the incidence and severity of side effects and gather real-world data on disease progression, particularly in the context of donanemab’s limited-duration treatment approach. These measures, together with the approved modified titration regimen, have improved the benefit-risk balance for donanemab with the aim of protecting people at greatest risk of harmful side effects.
Alzheimer Europe welcomed the November 2024 approval of the anti-amyloid therapy lecanemab, following re-examination by the CHMP. However, the organisation was disappointed by the delays caused by the Standing Committee for Medicinal Products for Human Use (SCMP) asking the CHMP to reconsider its positive opinion and then failing to reach a qualified majority decision in favour or against the treatment, requiring escalation to the Appeal Committee, which similarly did not reach a decision. On 15 April, five months after the November positive opinion of the CHMP, the European Commission finally decided to follow the CHMP’s initial positive opinion and provided a marketing authorisation for lecanemab - far beyond the 67 days foreseen under the EU’s centralised procedure for authorising medicines. Alzheimer Europe calls for similar delays to be avoided for donanemab.
Jean Georges, the Executive Director of Alzheimer Europe stated: “The positive opinion on donanemab marks an important step forward, offering a second approved disease-modifying therapy for early Alzheimer’s disease in Europe and expanding treatment options through its distinct dosing and stopping regimen. We hope that this opinion will lead to a prompt marketing authorisation by the European Commission, so that discussions on access, pricing, and reimbursement can proceed at national level. As with all anti-amyloid therapies, concerns around safety remain, and ongoing vigilance will be essential to ensure a favourable benefit-risk balance in real-world use.”
The positive opinion from the CHMP is an important advance for Europeans affected by Alzheimer’s disease. At the same, Alzheimer Europe recognises that donanemab will only benefit a small fraction of people with the disease. The organisation therefore reiterates its call for continued research into other treatment options, including symptomatic therapies, treatments for people in more advanced stages of the disease and with other types of dementia. In addition, Alzheimer Europe remains committed to a holistic approach where treatments are included alongside counselling, support and care of people with dementia and their carers throughout the disease process.
EMA information on the positive opinion can be accessed here:
https://www.ema.europa.eu/en/medicines/human/EPAR/kisunla
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For further information, contact: Jean Georges, Executive Director, Alzheimer Europe, 5, Heienhaff, L-1736 Luxembourg, Tel.: +352-29 79 70, Fax: +352-29 79 72, jean.georges@alzheimer-europe.org, www.alzheimer-europe.org
Previous positions of the organisation on anti-amyloid therapies can be found here:
Alzheimer Europe (2024). Alzheimer Europe position on anti-amyloid therapies (https://www.alzheimer-europe.org/sites/default/files/2024-01/2023-09_ae_call_for_action_on_anti-amyloid_treatments.pdf)
Alzheimer Europe (2025). Alzheimer Europe statement on the re-examination of the marketing authorisation of donanemab by the European Medicines Agency (https://www.alzheimer-europe.org/policy/positions/alzheimer-europe-statement-re-examination-marketing-authorisation-application)
Notes to editors:
Alzheimer Europe is the umbrella organisation of national Alzheimer associations and currently has 41 member organisations in 36 European countries.
Declaration of interests: Alzheimer Europe had an audited income of EUR 3,126,949 in 2024. Sponsorship by the developing company of donanemab (Lilly) amounted to EUR 80,000 or 2.56% of total income. Sponsorship by pharmaceutical companies is only accepted in accordance with the organisation’s Sponsorship guidelines and in line with the European Medicines Agency criteria for patient organisations, declared in full transparency on the Alzheimer Europe website: https://www.alzheimer-europe.org/Alzheimer-Europe/Finances2/AE-Sponsors