DSRU paper on lecanemab pharmacovigilance perspective

Our paper on lecanemab, a new anti-amyloid drug to treat Alzheimer’s Disease, emphasises the need for robust pharmacovigilance monitoring in order to determine its safety and efficacy in the real-world.

Lecanemab is one of a number of humanised IgG1 anti-amyloid monoclonal antibodies (mAb) which provide a promising novel treatment pathway with potential disease-modifying affects in early Alzheimer’s Disease. The drug was approved by the US FDA in July 2023 and subsequently received marketing authorisation in several other countries including the UK in August 2024. However clinical trials on anti-amyloid mAbs, including lecanemab, have highlighted risks including serious adverse events (SAEs), notably Amyloid–Related Imaging Abnormalities (ARIA) and the potential for rare, life-threatening events. In July 2024 the European Medicines Agency (EMA) rejected a marketing authorisation application, while in the UK the National Institute for Health and Care Excellence (NICE) opted not to recommend lecanemab for use in the National Health Service (NHS) amid concerns regarding the translation of outcomes of efficacy into clinically meaningful improvement. Subsequently, the EMA recommended the marketing authorisation approval of lecanemab in November 2024 following a re-examination of further data submitted by the Marketing Authorisation Holder.

Our narrative review discusses the requirement for a robust method for monitoring the safety and effectiveness of lecanemab in the real-world clinical setting, including an assessment of adherence to the proposed Risk Minimisation Measures (RMMs) within the context of limited resource availability to healthcare systems, such as the UK’s National Health Service (NHS).

Read the paper here