Alzheimer's Drug Gets FDA Panel's Backing, Setting the Stage for Broader Use
U.S. News & World Report WASHINGTON (AP) Health advisers on Friday unanimously backed the full approval of a closely watched Alzheimers 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 approva l 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 agencys 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 by July 6.
The FDAs initial OK for Leqembi came via the agencys accelerated approval program, which allows early access to drugs based on laboratory and 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 Alzheimers.
