Health advisers on Friday 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 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. But concerns about the cost and effectiveness of new plaque-targeting drugs like Leqembi have attracted new scrutiny to the process from academics, members of Congress and health insurers.
Facing pressure from Alzheimer’s advocates and patients, Medicare’s administrator, Chiquita Brooks-LaSure, has made clear the program will immediately begin covering the drug if it gets FDA’s full OK.
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