Alzheimer’s drug now has full FDA approval, which means Medicare will pay for it
FILE – This image provided by Eisai in January 2023 shows vials and packaging for their medication, Leqembi. (Eisai via AP, File)
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.
Leqembi, from drugmakers Eisai and Biogen, is the first medication that’s been shown to slow the progression of Alzheimer’s disease, including declines in memory and thinking, by targeting the disease’s underlying biology, CBS News reports.
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.
(Copyright 2023 The Associated Press contributed to this report. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.)
