Posted on 07/12/23
| News Source: Newsmax
Leqembi, the first drug shown to slow the rate of cognitive decline for people with early forms of Alzheimer’s disease, may not work as well for women. The Food and Drug Administration granted full approval to Leqembi last week, triggering a process that could expand coverage of the $26,500 treatment to millions of patients. Clinical trials revealed that Leqembi could delay cognitive decline by 27% over 18 months.
But according to Axios, a supplementary index to the study results published in the New England Journal of Medicine pointed out that the drug slowed cognitive decline in women by only 12% compared to 43% in men. Since nearly two-thirds of Americans living with Alzheimer’s disease are female, and the drug itself has significant side effects, a few experts are questioning whether the benefits outweigh the risks even without considering gender disparities.
“To me, it’s likely that males are benefiting more from this drug than females are,” said Dr. Madhav Thambisetty, senior investigator and chief at the clinical and translational neuroscience section of the National Institute on Aging. Eisai, the pharmaceutical company that developed Leqembi, countered that the gender disparities were not statistically significant, and the medication was effective in both sexes.
Dr. Christopher van Dyck, the lead researcher on Leqembi’s clinical trial and director of the Alzheimer’s Disease Research Unit at Yale School of Medicine, said “based on this data, if you have to make a bet on a male versus a female subject, how well they would do or likely benefit, absolutely, you’d bet on the male.”
The new data is influencing how clinicians say they will address Leqembi with their patients, especially women. Some say they will still consider treating female patients with the drug, while others say that their concerns about the risky side effects coupled with the gender disparity will temper their recommendations.
“I think it is a point of caution. It’s one of those things where you shouldn’t view this as a definitive answer, but it does temper their results, where you’re looking at this and saying, it doesn’t look like the women benefitted nearly as much as the men did,” noted Dr. Matthew S. Schrag, a board-certified vascular neurologist and assistant professor of neurology at Vanderbilt University Medical Center. He added that the benefit is small for all subgroups, especially in light of the drug’s risk. “I don’t think there’s any group of patients that I would recommend this drug to.”