Lecanemab, a recently approved Alzheimer’s-modifying drug, has shown promise since its approval by the U.S. Food and Drug Administration (FDA) in 2023. Known by its brand name, Leqembi, it has steadily gained market traction, with sales reaching $87 million USD in the last quarter of 2024. In Phase 3 clinical trials, lecanemab demonstrated an overall 27% reduction in cognitive decline, marking it as a significant advancement in Alzheimer’s treatment. However, a closer look at the data revealed a concerning discrepancy in its effectiveness between male and female patients, with some results suggesting little to no benefit in women.
This gender-based difference in the drug’s impact has sparked debate, with the FDA committee ultimately voting unanimously that the Phase 3 trial demonstrated a clinical benefit for the drug overall. Despite this, follow-up studies have raised questions about whether lecanemab should be prescribed to female patients given the apparent disparity in results.
To investigate this further, McGill PhD candidate Daniel Andrews, in collaboration with neuroscientist Prof. Louis Collins, analyzed publicly available Alzheimer’s patient data to simulate the original Phase 3 trial conditions. Their findings confirmed that lecanemab appeared to be less effective in females compared to males. However, the data did not support the conclusion that the drug was entirely ineffective in women, signaling the need for further research and analysis.
Moreover, the potential for serious side effects in some patients, coupled with the observed gender differences in efficacy, highlights the importance of tailored treatment strategies. Andrews’ and Collins’ findings offer valuable insights that may help clinicians make more informed decisions when prescribing lecanemab, weighing the potential benefits against risks, particularly for female patients. These results could also influence future approval processes in other countries and shape how upcoming clinical trials account for gender differences in drug response.
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