Since receiving approval from the U.S. Food and Drug Administration (FDA) in 2023, the Alzheimer’s drug lecanemab—sold under the brand name Leqembi—has seen steady growth in sales, reaching $87 million in the final quarter of 2024.
Lecanemab is only the second drug approved that may slow the progression of Alzheimer’s disease.
In a major Phase 3 clinical trial, lecanemab was shown to slow memory and thinking decline by about 27% overall. However, a closer look at the data raised questions.
Some results suggested that the drug might not be as effective for women as it is for men, though researchers couldn’t say why. Despite this uncertainty, an FDA committee unanimously agreed that the trial proved the drug offers clinical benefits.
Even so, several scientific papers followed the trial and focused on the possible difference in how the drug works in males versus females. Some experts were concerned this might mean lecanemab shouldn’t be recommended for female patients.
To find out whether there was truly a difference in how lecanemab works for men and women, Daniel Andrews, a PhD student at McGill University, worked with a research team led by neuroscientist Professor Louis Collins.
They used real-world data from Alzheimer’s patients and created simulated trials that closely followed the design of the original lecanemab trial. These simulations matched the ages, health profiles, and other factors used in the actual study.
Their findings confirmed that lecanemab likely had a smaller effect in women compared to men. However, the data did not show that the drug was completely ineffective for women. While women may not benefit as much, the drug could still help some female patients.
Lecanemab can also cause serious side effects in some people. With this new research, doctors may be better able to weigh the possible benefits and risks when deciding whether to prescribe the drug to female patients. These findings could also influence whether other countries approve the drug in the future.
The research also points to the need for future drug studies to more carefully consider sex differences from the beginning. Doing so could improve the way new treatments are developed, tested, and prescribed for all patients.
If you care about Alzheimer’s, please read studies about Vitamin D deficiency linked to Alzheimer’s, vascular dementia, and Oral cannabis extract may help reduce Alzheimer’s symptoms.
For more information about brain health, please see recent studies about Vitamin B9 deficiency linked to higher dementia risk, and results showing flavonoid-rich foods could improve survival in Parkinson’s disease.
The study is published in Alzheimer’s & Dementia.
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