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The effectiveness of Alzheimer's-modifying drugs-lecanemab may vary between genders
Since becoming only the second Alzheimer's-modifying drug to reach the US Federal Drug Administration in 2023, sales of lecanemab, known by the brand name Leqembi, have risen steadily in the final quarter of 2024, reaching $87 million. In its Phase 3 clinical trial, lecanemab slowed cognitive decline by 27 percent overall, but a subset of data suggested little to no benefit in women, although the cause of the difference was not clear. An FDA committee unanimously voted that the Phrase 3 trial assessed the clinical benefit of lecanemab. Nevertheless, several follow-up papers focused on the apparent...
The effectiveness of Alzheimer's-modifying drugs-lecanemab may vary between genders
Since becoming only the second Alzheimer's-modifying drug to reach the US Federal Drug Administration in 2023, sales of lecanemab, known by the brand name Leqembi, have risen steadily in the final quarter of 2024, reaching $87 million.
In its Phase 3 clinical trial, lecanemab slowed cognitive decline by 27 percent overall, but a subset of data suggested little to no benefit in women, although the cause of the difference was not clear. An FDA committee unanimously voted that the Phrase 3 trial assessed the clinical benefit of lecanemab. Nevertheless, several follow-up papers focused on the apparent gender difference in the trial to encourage women to prescribe lecanemab for women.
To test whether the LeCanemab study truly showed a sex difference in drug effectiveness, McGill PhD candidate Daniel Andrews, in collaboration with researchers led by neuroscientist Prof. Louis Collins, conducted simulated studies of openly available Alzheimer's disease patient data. They found that lecanemab was actually less effective than in men in the phase 3 trial. However, there was not enough evidence to show that the drug was completely ineffective in women.
LeCanemab causes serious side effects in some patients. Andrews and Collins' findings should better prepare clinicians to decide whether the potential benefits of lecanemab outweigh the potential harms in female patients and may influence future consideration of the drug's approval in other countries. The results also suggest how future drug trials can better account for sex differences.
Their results were published in theJournal of the Alzheimer's AssociationOn January 29, 2025.
Sources:
Andrews, D.,et al. (2025). The higher benefit of lecanemab in males compared to females in CLARITY AD is probably due to a real sex effect. Alzheimer’s & Dementia. doi.org/10.1002/alz.14467.