The US Food and Drug Administration on Friday approved a new Alzheimer’s drug that may fairly 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, which is to be marketed as Leqembi, is expected to generate considerable interest from patients and physicians. The drug is an intravenous infusion administered every two weeks. Studies of the drug suggest that it is more promising than the limited number of other treatments available.
Several Alzheimer’s experts, however, said it was unclear from the medical evidence whether Leqembi could slow cognitive decline enough to be noticeable to patients. 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 commercialisation and marketing, and the companies will split the profits equally.