- The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted a marketing authorisation for lecanemab for the treatment of early Alzheimer’s disease
- Alzheimer Europe welcomes the MHRA approval of lecanemab, as well as its considered approach to exclude those at greatest risk of side-effects, whilst enabling other people with early AD to make their own benefit-risk decisions together with their doctors
- While lecanemab was approved by regulatory authorities in China, Hong Kong, Israel, Japan, South Korea, the United Arab Emirates and the US, the European Medicines Agency issued a negative opinion on 26 July
- The organisation reiterates its disappointment regarding the negative opinion issued by the EMA and hopes that it will adopt a similar approach to the MHRA following its re-examination of the lecanemab opinion.
Luxembourg, 22 August 2024 – Today, the UK Medicines and Healthcare products Regulatory Agency (MHRA) announced the approval of lecanemab for the treatment of early Alzheimer’s disease (mild cognitive impairment and mild dementia due to Alzheimer's disease). The approval is based on data from the Phase 3 Clarity-AD study, which demonstrated a 27% reduction in clinical decline after 18 months of lecanemab treatment on the global cognitive and functional scale, CDR-SB. In its press release, the MHRA found that lecanemab met regulatory standards for safety, quality and effectiveness. The National Institute for Health and Care Excellence (NICE) has also issued draft guidance on the use of lecanemab, stating that its clinical benefits are too small to justify the costs of the drug to the National Health Service (NHS). A public consultation is ongoing, with a final recommendation on coverage expected towards the end of 2024.
Alzheimer Europe welcomes the positive decision by the MHRA, which represents an important advance for the Alzheimer’s disease community in the UK and hopes that NICE will recommend NHS coverage for lecanemab in its final decision.
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. Lecanemab has also been approved for treatment of early Alzheimer’s disease by regulatory authorities in Japan, China, South Korea, Hong Kong, Israel and the United Arab Emirates. The positive recommendation from the MHRA means that people with Alzheimer’s disease in the UK will also have access to treatment options that are available to patients in the US and other countries. Alzheimer Europe reiterates its disappointment about the negative opinion of the European Medicines Agency on 26 July, which may exclude Europeans from accessing lecanemab, worsening inequities in access to novel treatments for Alzheimer’s disease.
Alzheimer Europe appreciates and supports the considered approach that the MHRA has taken to manage the risks associated with lecanemab treatment and exclude those most likely to develop amyloid-related imaging abnormalities (ARIA), potentially harmful side-effects which are linked to brain swelling and micro-bleeds. The MHRA has limited the indication for lecanemab to exclude people with two copies of the ApoE4 gene, those on antithrombotic medicines and people who have been diagnosed with cerebral amyloid angiopathy, all of whom are at greater risk of developing ARIA. A controlled post-authorisation safety study will be conducted to investigate the safety and benefit-risk profile of lecanemab in routine clinical practice.
The FDA adopted a similar approach to manage risk, including a black box warning of ARIA in the prescribing information for lecanemab, stating that genetic testing for ApoE4, should be performed prior to initiating treatment. In adopting this approach, regulators enable patients to make individual choices based on a personal analysis of treatment benefits and risks. To support decision-making, Alzheimer Europe emphasises the importance of accessible, inclusive communication of the benefits, risks, costs and logistical burdens of treatment, as outlined in the organisation’s position paper on anti-amyloid therapies for Alzheimer’s disease.
Jean Georges, the Executive Director of Alzheimer Europe stated: “We welcome the approval of lecanemab by the MHRA, enabling people with early Alzheimer’s disease in the UK to access a disease-modifying drug that is available in many other countries. We now look to health authorities to ensure access to lecanemab in the UK, and to prepare the healthcare system for delivering timely diagnoses for people with early Alzheimer’s disease, together with efficient safety monitoring for potential side effects.”
Approval of the lecanemab marketing authorisation application by the MHRA is a major step forward for people affected by Alzheimer’s disease in the UK. While we regret the negative opinion of the EMA, Alzheimer Europe hopes that re-examination of the opinion will result in an outcome that enables more Europeans living with early Alzheimer’s disease to access lecanemab in the future. In addition, the organisation 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.
Read the MHRA press release: https://www.gov.uk/government/news/lecanemab-licensed-for-adult-patients-in-the-early-stages-of-alzheimers-disease
Read the NICE press release: https://www.nice.org.uk/news/articles/benefits-of-new-alzheimer-s-treatment-lecanemab-are-too-small-to-justify-the-cost-to-the-nhs
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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
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 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/about-us/governance/finances/alzheimer-europe-sponsors