WASHINGTON (NEWSnet/AP) — Health advisers on Friday unanimously backed 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 disease.

In January, Leqembi received conditional approval from the Food and Drug Administration, based on early results suggesting it could slow Alzheimer's progression. Now, FDA is reviewing more definitive results to decide whether the drug should receive the agency’s full endorsement.

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 by July 6.

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 to clear a brain plaque that is a hallmark of Alzheimer’s.

FDA's panel reviewed more recent data from 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Drugs approved via the accelerated pathway can be withdrawn by FDA if benefits aren't confirmed, although regulators rarely take that step. Gaining full approval allows medications to stay on the market indefinitely.

Typically, the process of converting an accelerated approval attracts little attention, and FDA rarely convenes its advisers to assess such decision But concerns about the cost and effectiveness of new plaque-targeting drugs similar to Leqembi have attracted new scrutiny to the process from academics, members of Congress and health insurers.

Medicare, the federal health plan that covers 60 million seniors, essentially blocked coverage for Leqembi and a similar drug, Aduhelm, pending full FDA approval.

Facing pressure from Alzheimer’s advocates and patients, Medicare’s administrator, Chiquita Brooks-LaSure, has made clear the program will begin to offer coverage for cost of the drug immediately, if it gets FDA’s full OK.

But last week she announced extra requirements even after Medicare coverage begins: All patients receiving the drug will need to be enrolled in a federal registry to track Leqembi's safety and effectiveness. That approach is occasionally used for complex new medical devices, but rarely for drugs.

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