Since he is only the second Alzheimer-modifying medicine to get the American federal drug administration approval in 2023, the sale of Lecanemab, known under the brand name Leqembi, has steadily risen and reached $ 87 million in the last quarter of 2024.
In his phase 3 Clinical study, Lecanemab delayed the cognitive decrease of 27 percent in general, but one 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 test has verified the clinical benefit of Lecanemab. Nevertheless, various follow -up documents focused on the apparent sex reinforcement result of the test to evoke doubt about prescribing lecanemab to women.
To test whether the Lecanemab test has really demonstrated a sex difference in the effectiveness of drugs, McGill -Promovendus Daniel Andrews, in collaboration with researchers led by neuroscientist Prof. Louis Collins, carried out simulated studies on openly available Alzheimer data, with patient data. They discovered that Lecanemab was indeed probably less effective in women than men in the 3 -study phase. However, there was insufficient evidence to say that the medicine was completely not effective in women.
In some patients, Lecanemab causes serious side effects. The findings of Andrews and Collins should better prepare clinicians to decide whether the potential benefits of Lecanemab are more important than the possible damage to female patients, and to inform the future consideration of the approval of the drug in other countries. The findings also suggest ways in which future drug tests can better explain sex differences.
Their results were published in the Journal of the Alzheimer’s Association on January 29, 2025.
Source:
Journal Reference:
Andrews, D., et Alt Alto. (2025). The higher advantage of lecanemab in men compared to women in the clarity AD is probably due to a real sex effect. Alzheimer and dementia. doi.org/10.1002/alz.14467.