U.S. health advisers are backing the full approval of an Alzheimer's drug that received preliminary approval last year
FILE - This Dec. 21, 2022, image provided by Eisai in January 2023 shows vials and packaging for their medication Leqembi. On Friday, June 9, 2023, health advisers backed the full approval of the closely watched Alzheimer’s drug, a key step toward opening insurance coverage to U.S. seniors with early stages of the brain-robbing disease.
The FDA’s initial OK for Leqembi came via the agency’s accelerated approval program, which allows early access to drugs based on laboratory or biological measures suggesting that they might help patients. The drug, marketed by Eisai and Biogen, helped clear a brain plaque that is a hallmark of Alzheimer’s.in which people taking the drug showed a modestly slower rate of decline on measures of memory, judgment and other cognitive tests.
Drugs approved via the accelerated pathway can technically be withdrawn by the FDA if their benefits aren't confirmed, though regulators rarely take that step. Gaining full approval allows medications to stay on the market indefinitely.
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