Health advisers on Friday unanimously backed the full approval of a closely watched Alzheimer's drug, a key step toward opening insurance coverage to U.S. seniors with early stages of the brain-robbing disease.
, Leqembi, received conditional approval from the Food and Drug Administration in January based on early results suggesting it could slow Alzheimer's progression by several months. The FDA now is reviewing more definitive results to decide whether the drug should receive the agency's full endorsement.
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.
Drugs approved via the accelerated pathway can technically be withdrawn by the FDA if their benefits aren't confirmed, though regulators rarely take that step.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. Medicare, the federal health plan that covers 60 million seniors, has essentially blocked coverage of Leqembi and a similar drug, Aduhelm, pending full FDA approval. That policy, which has little precedent, was announced last year amid concerns that Aduhelm, priced at $28,000-a-year, would drive up costs for Medicare recipients.
Belgique Dernières Nouvelles, Belgique Actualités
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