The Food and Drug Administration on Friday approved a new Alzheimer’s drug that may modestly slow the pace of cognitive decline early in the disease, but also carries risks of swelling and bleeding in the brain.
The approval of the drug, lecanemab, to be marketed as Leqembi, is likely to generate considerable interest from patients and physicians. Studies of the drug — an intravenous infusion administered every two weeks — suggest it is more promising than the scant number of other treatments available. Still, several Alzheimer’s experts said it was unclear from the medical evidence whether Leqembi could slow cognitive decline enough to be noticeable to patients.
Even a recent report of findings from a large 18-month clinical trial, published in the New England Journal of Medicine and co-written by scientists from the lead company making the drug, concluded that “longer trials are warranted to determine the efficacy and safety of lecanemab in early Alzheimer’s disease.”
Eisai, a Japanese pharmaceutical company, led the development and testing of the drug. It is partnering with the American company Biogen, maker of the controversial Alzheimer’s drug Aduhelm, for its commercialization and marketing, and the companies will split the profits equally.
It is equally noteworthy that its price is prohibitive, $26,500 a year.
In its decision, the F.D.A. appeared to be acknowledging the vehement criticism that erupted when it approved Aduhelm in 2021 after both a committee of independent advisers and an F.D.A. council of senior officials said there was not enough evidence that it worked. With Leqembi, the F.D.A. included narrower and more cautionary language on the drug label than it initially had with Aduhelm.
