{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T20:24:01Z","timestamp":1792614241906,"version":"4.5.0"},"reference-count":44,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2025,3,6]],"date-time":"2025-03-06T00:00:00Z","timestamp":1741219200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Br J Clin Pharmacol"],"published-print":{"date-parts":[[2025,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>The development of humanized IgG1 anti\u2010amyloid monoclonal antibodies, such as lecanemab, provides a promising novel treatment pathway with potential disease\u2010modifying 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\u2010examination 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\u2010related imaging abnormalities (ARIA), have also emerged from clinical trial data with a concern for the potential for rare, life\u2010threatening events. This narrative review discusses the requirement for a robust method of monitoring the safety and effectiveness of lecanemab in the real\u2010world 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).<\/jats:p>","DOI":"10.1002\/bcp.70021","type":"journal-article","created":{"date-parts":[[2025,3,11]],"date-time":"2025-03-11T17:45:47Z","timestamp":1741715147000},"page":"1352-1360","source":"Crossref","is-referenced-by-count":24,"title":["Safety and effectiveness of the anti\u2010amyloid monoclonal antibody (mAb) drug lecanemab for early Alzheimer's disease: The pharmacovigilance perspective"],"prefix":"10.1002","volume":"91","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7587-4130","authenticated-orcid":false,"given":"Amy","family":"Bobbins","sequence":"first","affiliation":[{"name":"Drug Safety Research Unit  Southampton UK"},{"name":"School of Pharmacy and Biomedical Sciences University of Portsmouth  Portsmouth UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2949-8378","authenticated-orcid":false,"given":"Miranda","family":"Davies","sequence":"additional","affiliation":[{"name":"Drug Safety Research Unit  Southampton UK"},{"name":"School of Pharmacy and Biomedical Sciences University of Portsmouth  Portsmouth UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3905-1046","authenticated-orcid":false,"given":"Elizabeth","family":"Lynn","sequence":"additional","affiliation":[{"name":"Drug Safety Research Unit  Southampton UK"},{"name":"School of Pharmacy and Biomedical Sciences University of Portsmouth  Portsmouth UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2803-6323","authenticated-orcid":false,"given":"Debabrata","family":"Roy","sequence":"additional","affiliation":[{"name":"Drug Safety Research Unit  Southampton UK"},{"name":"School of Pharmacy and Biomedical Sciences University of Portsmouth  Portsmouth UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9125-0379","authenticated-orcid":false,"given":"Alison","family":"Yeomans","sequence":"additional","affiliation":[{"name":"Drug Safety Research Unit  Southampton UK"},{"name":"School of Pharmacy and Biomedical Sciences University of Portsmouth  Portsmouth UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4084-297X","authenticated-orcid":false,"given":"Saad A. 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