Alzheimer's drug gets FDA panel's backing, setting the stage for broader use
1 year, 6 months ago

Alzheimer's drug gets FDA panel's backing, setting the stage for broader use

The Hindu  

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 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 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. 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.

History of this topic

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