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Review
. 2025 May;91(5):1352-1360.
doi: 10.1002/bcp.70021. Epub 2025 Mar 6.

Safety and effectiveness of the anti-amyloid monoclonal antibody (mAb) drug lecanemab for early Alzheimer's disease: The pharmacovigilance perspective

Amy Bobbins  1   2 , Miranda Davies  1   2 , Elizabeth Lynn  1   2 , Debabrata Roy  1   2 , Alison Yeomans  1   2 , Saad A W Shakir  1   2
Affiliations
Review

Safety and effectiveness of the anti-amyloid monoclonal antibody (mAb) drug lecanemab for early Alzheimer's disease: The pharmacovigilance perspective

Amy Bobbins et al. Br J Clin Pharmacol. 2025 May.

Abstract

The development of humanized IgG1 anti-amyloid monoclonal antibodies, such as lecanemab, provides a promising novel treatment pathway with potential disease-modifying effects for patients with early Alzheimer's disease (AD). Lecanemab, which gained marketing approval by the United States Food and Drug Administration (US FDA) in July 2023, has since been approved in multiple countries, including the United Kingdom (UK). The decision by the UK's Medicines and Healthcare products Regulatory Agency (MHRA) to approve lecanemab in August 2024 followed similar regulatory decisions in the US and Japan. However, at the time of approval, the decision contrasted with that of the European Medicine Agency (EMA) in July 2024. Subsequently, the EMA recommended the marketing approval of lecanemab in November 2024 following a re-examination of further data submitted by the Marketing Authorisation Holder. The UK's National Institute for Health and Care Excellence (NICE) has not recommended lecanemab for use in early AD amid concerns, including treatment cost and the translation of efficacy outcomes into clinically meaningful improvement. The risks of serious adverse events (SAEs), including amyloid-related imaging abnormalities (ARIA), have also emerged from clinical trial data with a concern for the potential for rare, life-threatening events. This narrative review discusses the requirement for a robust method of monitoring the safety and effectiveness of lecanemab in the real-world clinical setting considering recent regulatory decisions. Additionally, the need to evaluate proposed risk minimization measures (RMMs) is discussed considering the resource constraints of healthcare systems, such as those faced by the UK's National Health Service (NHS).

Keywords: Alzheimer's disease; anti‐amyloid monoclonal antibodies; benefit–risk profile; dementia; lecanemab.

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Conflict of interest statement

None of the authors disclose any conflict of interest directly relevant or directly related to this work.

Figures

FIGURE 1
FIGURE 1
A timeline of major regulatory decisions for lecanemab.
See this image and copyright information in PMC

References

    1. van Dyck CH, Swanson CJ, Aisen P, et al. Lecanemab in early Alzheimer's disease. N Engl J Med. 2023;388(1):9‐21. doi:10.1056/NEJMoa2212948 - DOI - PubMed
    1. “LEQEMBI®” (lecanemab) approved for the treatment of Alzheimer's disease in the United Arab Emirates [press release]; 2024.
    1. National Institute for Health and Care Excellence (NICE) . Draft guidance consultation – lecanemab for treating mild cognitive impairment or mild dementia caused by Alzheimer's disease; 2024.
    1. European Medicines Agency (EMA) . Refusal of the marketing authorisation for Leqembi (lecanemab); 2024.
    1. Approval of the marketing authorisation for Leqembi (lecanemab) [press release]; 2024.

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