- Following a re-examination of its initial opinion, the Committee for Medicinal Products for Human use (CHMP) of the European Medicines Agency today issued a positive opinion on the marketing authorisation application for lecanemab for the treatment of early Alzheimer’s disease.
- The CHMP recommends excluding people with two copies of the ApoE4 gene and people on anticoagulants from treatment and requires the companies (Eisai and Biogen) to conduct a post-marketing authorisation safety study.
- Alzheimer Europe welcomes the cautious approach of the CHMP, which protects people at greatest risk of harmful side effects, such as amyloid-related imaging abnormalities (ARIA).
- Alzheimer Europe calls on national professional organisations and clinicians to develop clear communication material to present the efficacy and safety of lecanemab in realistic terms so as to allow shared and informed decision making with patients and their supporters.
- The organisation also calls on industry, payers, healthcare systems and governments to work together to ensure timely, safe, affordable and equitable access for patients, regardless of their socio-economic background, insurance status, or place of residence.
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 Eisai’s marketing authorisation application for lecanemab 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 lecanemab for a restricted population outweighed its risks, and therefore recommended approving the marketing authorisation application.
Alzheimer Europe welcomes the positive decision by the CHMP, which addresses many of the concerns highlighted in Alzheimer Europe’s official response to the initial CHMP decision, enabling patients to engage in discussions with their physicians and make informed decisions based on their individual circumstances, preferences and values, including the acceptability of risk and anticipated benefits.
Alzheimer Europe appreciates and supports the considered approach that the EMA has taken to identify patients likely to benefit from treatment and exclude those at greatest risk of harmful side-effects. During the re-examination, the CHMP focused on participants with only one or no copies of the ApoE4 gene, assessing data from a subgroup of 1,521 individuals out of the 1,795 participants in the Clarity-AD trial of lecanemab. In this group, the risk of amyloid-related imaging abnormalities (ARIA) was generally lower than in the full trial population, which included people with two copies of the ApoE4 gene.
As a result, the indication for lecanemab has been narrowed, to exclude people carrying two copies of the ApoE4 gene, as well as individuals receiving anticoagulant therapy. The CHMP has also mandated additional measures to reduce risk, including a controlled access programme, regular MRI scans for safety monitoring, and a post-authorisation study to assess the effectiveness of these risk minimisation measures. These measures have improved the benefit-risk balance for lecanemab, protecting people at greatest risk of harmful side effects such as ARIA.
Alzheimer Europe also welcomes the commitment from Eisai and Biogen to increase awareness of ARIA and ensure early management of side-effects, by providing guidance and training for healthcare professionals, as well as an alert card for patients. The companies will also set up an EU-wide registry study to estimate the incidence and severity of side effects and collect information about patients’ progression to the next stages of Alzheimer’s disease.
Jean Georges, the Executive Director of Alzheimer Europe, stated: “As with many other conditions, this first drug with a new mode of action constitutes an important advance for the Alzheimer’s disease community in Europe. We therefore welcome the positive outcome from the CHMP’s re-examination of lecanemab. In our position paper on anti-amyloid therapies, we called for timely, safe and equitable access to these medicines. We now look to companies to adopt reasonable and sustainable pricing policies and to payers to ensure lecanemab is covered by national reimbursement systems. Healthcare systems must also be adapted, so that people can receive an accurate, timely diagnosis with access to treatment and effective monitoring for potential side effects. The side effects and benefits of lecanemab will need to be communicated to people with early Alzheimer’s disease in realistic terms, in order to allow informed decision-making.”
Approval of the lecanemab marketing authorisation application by the EMA is a major step forward for Europeans affected by Alzheimer's disease. At the same time, Alzheimer Europe recognises that lecanemab 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.
The full press release from the EMA can be accessed here:
https://www.ema.europa.eu/en/news/leqembi-recommended-treatment-early-alzheimers-disease
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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 (2024). Alzheimer Europe response to the negative CHMP decision on lecanemab (https://www.alzheimer-europe.org/sites/default/files/2024-10/2024-09-30_response_to_negative_chmp_decision_on_lecanemab_0.pdf)
Declaration of interests: Alzheimer Europe had an audited income of EUR 2,404,596 in 2023. Sponsorship by the developing companies of lecanemab (Eisai and Biogen) amounted to EUR 37,500 or 1.56% 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