Health advisers unanimously backed the full approval of a closely watched Alzheimer’s drug, Leqembi. The decision carries extra significance because insurers have held off on paying for the infused treatment until it has full FDA approval.
June 9, 2023 GMT
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 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. “For an illness like this where we don’t have very much, these are meaningful changes for patients with Alzheimer’s,” said Dr. Merit Cudkowicz of Harvard Medical School. “A couple more months in the highly functional state is really meaningful.”
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