• The Committee for Medicinal Products for Human use (CHMP) of the European Medicines Agency today issued a negative opinion on the marketing authorisation application of Eisai for lecanemab for the treatment of early Alzheimer’s disease.

• Lecanemab has already been approved by regulatory authorities in China, Hong Kong, Israel, Japan, South Korea and the US.

• Alzheimer Europe therefore strongly regrets the negative CHMP opinion, which deprives Europeans with mild cognitive impairment or mild dementia due to Alzheimer’s disease from access to treatment options available elsewhere.

• Alzheimer Europe fears that this negative CHMP opinion takes away choice from all individuals with early Alzheimer’s disease, and advocates for individuals with Alzheimer’s disease and their families to be included in assessing the risk/benefit of new medicines.

• Alzheimer Europe hopes that other European regulators such as the UK Medicines and Healthcare products Regulatory Agency or Swissmedic will come to a positive recommendation.

• The organisation reiterates its call for continued research into other treatment options for Alzheimer’s disease and other dementias, including symptomatic treatments as well as therapies for people in more advanced stages.

Luxembourg, 26 July 2024 – 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 Eisai for lecanemab for the treatment of early Alzheimer’s disease (mild cognitive impairment or mild dementia due to Alzheimer’s disease). In its opinion, the CHMP found that the benefits of treatment are not large enough to outweigh the risks associated with lecanemab.

Alzheimer Europe regrets this negative decision by the CHMP. People living with Alzheimer’s disease and their families had high hopes and expectations about the introduction of new treatment options in Europe. The US Food and Drug Administration (FDA) granted traditional approval to lecanemab in July 2023, after unanimous endorsement of its clinical efficacy by an advisory committee. Key US payers including Medicare agreed to provide broad coverage for lecanemab, for eligible patients with
early Alzheimer’s disease. Lecanemab has also been approved for treatment of early Alzheimer’s disease by regulatory authorities in Japan (25 September 2023), China (3 January), South Korea (27 May), Hong Kong (11 July) and Israel (12 July).

The refusal by the EMA means that Europeans with early Alzheimer’s disease will not have access to treatment options that are available to patients in the US and other countries. The EMA decision will affect people with Alzheimer’s disease in the European Union, Iceland, Liechtenstein and Norway. Separate applications are pending with Swissmedic and the Medicines and Healthcare products Regulatory Agency for patients in Switzerland and the United Kingdom and Alzheimer Europe hopes that these regulatory agencies will come to a positive decision.

After several high-profile failures, recent clinical trials of lecanemab and other anti-amyloid drugs had marked a turning point for the field. The global Phase 3 Clarity AD study met all its primary and secondary endpoints, demonstrating a 27% reduction in clinical decline after 18 months of lecanemab treatment on the global cognitive and functional scale, CDR-SB. Side effects including brain swelling and microbleeds (termed “amyloid-related imaging abnormalities”, or ARIA) were relatively common, with severe symptoms reported in 0.7% of trial participants. To address these safety concerns, the FDA included a black box warning of ARIA in the prescribing information for lecanemab, stating that genetic testing for ApoEε4, a risk factor for ARIA, should be performed prior to initiating treatment. Regular monitoring with MRI scans was also recommended by the US regulator.

Alzheimer Europe welcomed the traditional approval of lecanemab by the FDA, as well as the considered approach to identify patients most likely to benefit from treatment and exclude those at greatest risk of harmful side-effects. The Alzheimer Europe position paper on anti-amyloid therapies1 for Alzheimer’s disease underlined the importance of equitable access to these innovative treatments, with inclusive communications allowing patients to weigh the potential slowing of clinical decline against the side effects, costs and burdens of treatment.

The organisation is deeply disappointed that people with Alzheimer’s disease in Europe will now be excluded from access to lecanemab, without the possibility to make individual choices based on a personal analysis of treatment risks and benefits. Alzheimer Europe hopes that real-world findings from the FDA-mandated patient registry, or from ongoing trials of lecanemab, will provide the necessary scientific evidence for EU regulators to reconsider their position.

Jean Georges, the Executive Director of Alzheimer Europe stated: “We understand that lecanemab is not a wonder drug for all people with Alzheimer’s disease. However, the existence of a first disease-modifying drug, with a novel mode of action, constitutes an undeniable, major advance for a field which has been waiting for new medicines for over two decades. Lecanemab has demonstrated effects on disease progression, as well as on secondary endpoints such as quality of life and caregiver burden. Instead of excluding all patients from this new treatment due to safety concerns, we would have hoped that the European Medicines Agency would authorise the medicine with a clear risk management plan to address potential side effects.”

The negative opinion on the lecanemab marketing authorisation approval by the EMA represents a major setback for the Alzheimer’s disease community in Europe. However, Alzheimer Europe remains encouraged by the number of companies and organisations continuing to invest in research and the new treatment options currently being developed. The organisation therefore reiterates its call for continued research into other treatment options, including symptomatic therapies and treatments for people in more advanced stages of dementia.

In addition, Alzheimer Europe remains committed to a holistic approach to Alzheimer’s disease and other types of dementia where innovative new treatments are included alongside counselling, support and adequate care of people with dementia and their carers throughout the disease process. You can find details of the CHMP recommendation here: https://www.ema.europa.eu/en/medicines/human/EPAR/leqembi and the Eisai
press release here: https://www.eisai.com/news/2024/news202455.html

For further information, contact: Jean Georges, Executive Director, Alzheimer Europe a.s.b.l., 5, Heienhaff, L-1736 Luxembourg, Tel.: +352-29 79 70, Fax: +352-29 79 72, jean.georges@alzheimer-europe.org, www.alzheimer-europe.org
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 EUR2,404,596 in 2023. Sponsorship by the developing companies of lecanemab (Eisai and Biogen) amounted to EUR37,500 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/about-us/governance/finances/alzheimer-europe-sponsors1

https://www.alzheimer-europe.org/policy/positions/alzheimer-europe-position-anti-amyloid-therapies