WASHINGTON (AP) — U.S. officials have granted full approval to a closely watched Alzheimer's drug for patients with early stages of the disease.
The Food and Drug Administration decision clears the way for Medicare and other insurers to begin paying for the drug called Leqembi.
The FDA gave it conditional approval in January based on early results suggesting the drug could modestly slow cognitive decline.
FDA officials said Thursday that the drug's benefits have now been confirmed. The drug will carry a warning about potentially serious side effects, including brain swelling and bleeding.
Patients getting the drug through Medicare will need to enroll in a federal registry tracking the drug's safety and effectiveness.
