Leqembi® ▼ (lecanemab) proposed Marketing Authorisation Variation for monthly intravenous maintenance dosing for the treatment of early Alzheimer’s disease (AD) in the UK is validated for evaluation by the MHRA

Proposed intravenous maintenance dosing application to reduce lecanemab infusion frequency from every two weeks to every four weeks for eligible adult UK patients after initial 18 months of treatment

The variation application will be evaluated by the Medicines and Healthcare products Regulatory Agency, which will decide whether to approve or reject the proposal

HATFIELD, HERTFORDSHIRE, UNITED KINGDOM (UK), and MAIDENHEAD, UK, 30 APRIL, 2025 – Eisai Europe Ltd. and Biogen Idec Ltd. announced today that the Medicines and Healthcare products Regulatory Agency (MHRA) has validated a proposed Marketing Authorisation Variation for monthly lecanemab dosing for eligible adult patients with early Alzheimer’s disease (AD) in the UK, after an initial 18 months of treatment at the currently approved dosing regimen. The variation application will now be evaluated by the MHRA to decide whether to approve or reject the proposal.

Currently, lecanemab is licenced as an intravenous (IV) infusion once every two weeks (10 mg/kg).¹ If approved, this application may enable the dosing frequency to decrease to once every four weeks, after eligible patients have completed the initial 18 months of treatment every two weeks.

The submission is part of Eisai and Biogen’s ongoing commitment to addressing the unmet needs of people living with AD, healthcare systems and wider society. Maintenance dosing is an important step forward in providing flexibility to eligible patients and healthcare professionals in managing this chronic, progressive disease.^2,3

AD is a chronic disease which progresses in stages and increases in severity over time.² AD is the leading cause of death in the UK,⁴ with early AD usually being the first stage of the disease where symptoms become noticeable, such as forgetting recent events or conversations.^5,6 As AD progresses, everyday activities, hobbies and social engagements become more challenging, and independence is lost.^5,6

Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercialising and co-promoting the product and Eisai having final decision-making authority. In the UK, Eisai and Biogen co-promote the medicine, with Eisai distributing the product as the Marketing Authorisation Holder.

▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. If you have any side effects, talk to your healthcare professional. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play and Apple App store. By reporting side effects, you can help provide more information on the safety of this medicine.

References

1.       Lecanemab United Kingdom Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/15908. Last accessed: April 2025.

2.       European Brain Council. Alzheimer’s Disease fact sheet. Available at: https://www.braincouncil.eu/wp-content/uploads/2021/02/A4-Alzheimers-Disease-Fact-Sheet-Final.pdf. Last accessed: April 2025.

3.       Alzheimer Society. What is Alzheimer's disease? Available at: https://alzheimer.ca/en/about-dementia/what-alzheimers-disease. Last accessed: April 2025.

4.       National Institute for Health and Care Excellence (NICE). 2025. Draft guidance consultation: Lecanemab for treating mild cognitive impairment or mild dementia caused by Alzheimer’s disease. Available at: https://www.nice.org.uk/guidance/indevelopment/gid-ta11220/documents. Last accessed: April 2025.

5.       Alzheimer’s Association. Stages of Alzheimer’s. Available at: https://www.alz.org/alzheimers-dementia/stages. Last accessed: April 2025. 

6.       Morris, J.C. The Clinical Dementia Rating (CDR): current version and scoring rules. Neurology. 1993;43:2412-2414.

7.       U.S. Food and Drug Administration. 2023. FDA Converts Novel Alzheimer’s Disease Treatment to Traditional Approval. Last accessed: April 2025.

8.       Reuters. 2023. Japan approves Alzheimer's treatment Leqembi by Eisai and Biogen. Last accessed: April 2025.

9.       The Pharma Letter. 2024. Brief - Alzheimer drug Leqembi now approved in China. Last accessed: April 2025.

10.    Pharmaceutical Technology. 2024. South Korea’s MFDS approves Eisai-Biogen’s Leqembi for Alzheimer’s. Last accessed: April 2025.

11.    Pharmaceutical Technology. 2024. Hong Kong approves Leqembi for Alzheimer’s treatment. Last accessed: April 2025.

12.    Pharmaceutical Business Review. 2024. Leqembi gains approval for Alzheimer’s treatment in Israel. Last accessed: April 2025.

13.    Pharmaceutical Technology. 2024. UAE approves BioArctic and Eisai’s Leqembi for Alzheimer’s disease. Last accessed: April 2025.

14.    The Pharma Letter. 2024. Brief - Mexican approval for Alzheimer’s drug Leqembi. Last accessed: April 2025.

15.    Eisai Co., Ltd. 2025. FDA Accepts LEQEMBI^® (lecanemab-irmb) Biologics License Application for Subcutaneous Maintenance Dosing for the Treatment of Early Alzheimer’s Disease. Last accessed: April 2025.

16.    Eisai Co., Ltd. 2025. Update on Regulatory Review of Lecanemab for Early Alzheimer’s Disease by the European Commission. Last accessed: April 2025.

17.    Lecanemab European Union Summary of Product Characteristics. Available at: https://ec.europa.eu/health/documents/community-register/html/h1891.htm. Last accessed: April 2025.