Alzheimer's Drug Receives Experts' Support for Approval

Health advisers on Friday unanimously backed the full approval of a closely watched Alzheimer's drug, a key step toward opening insurance coverage to US 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 AP reports.

The 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 by July 6. The FDA's initial OK 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 an 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.

"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. Medicare 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. Leqembi is priced similarly at $26,500 per year, per the AP, and the handful of patients who have received it to date have mainly had to pay out of pocket. "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."

(More Alzheimer's disease stories.)