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Health advisers 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.
The drug, 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 decision carries extra significance because insurers have held off on paying for the infused treatment until it has full FDA approval.
The FDA panel of outside advisers voted 6-0 that a large company study confirmed the drug’s benefits for patients with mild or early Alzheimer’s. The nonbinding vote amounts to a recommendation for full approval, and the FDA is scheduled to issue a final decision on the matter.
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.
The FDA panel reviewed more recent data from a 1,800-patient study 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Drugs approved via the accelerated pathway can technically be withdrawn by the FDA if their benefits aren’t confirmed, though regulators rarely take that step.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.
Leqembi is the first drug that’s been convincingly shown to slow Alzheimer’s by targeting the underlying biology of the disease. The delay in progression amounts to about five months, and some experts disagree on whether that difference is enough to meaningfully improve people’s lives.
But most FDA panelists were impressed by Eisai’s results, which they said showed significant differences in patients’ cognitive abilities and functionality, as well as a reduced burden for caregivers.
“There are adverse effects,” said Dr. Robert Alexander of the University of Arizona, who chaired the panel. “But they’re monitorable and I think the benefit is clear.”
This article was provided by The Associated Press.