F.D.A. Approves New Treatment for Early Alzheimer’s

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.

Eisai said the list price for Leqembi (pronounced le-KEM-bee) would be $26,500 per year. The price is slightly lower than Aduhelm’s, but higher than that recommended by some analysts.

“Based on our draft results, that price would not meet typical cost-effectiveness thresholds,” said Dr. David Rind, the chief medical officer for the Institute for Clinical and Economic Review, an independent nonprofit organization that assesses the value of medicines. In a preliminary report last month, the institute said that to be cost-effective for patients, the price should be set between $8,500 and $20,600 a year.