Expert advisers to the Food and Drug Administration on Friday voted unanimously in favor of expanding the approval of Leqembi, an Alzheimer’s disease treatment from Eisai and Biogen, further clearing the way for what could be the first widely available medicine that delays the disease’s progress.
The group voted 6-0 that an 1,800-patient study of Leqembi confirmed its benefits for patients in the early stages of Alzheimer’s, recommending the FDA widen the drug’s limited approval. The agency, which is not required to follow the suggestions of its advisers, is expected to make a final decision on Leqembi by July 6.
“I thought the clinical results were robust,” said Merit Cudkowicz, a neurologist from Massachusetts General Hospital and one of the experts invited to review Leqembi.
Exciting news! STAT has moved its comment section to our subscriber-only app, STAT+ Connect. Subscribe to STAT+ today to join the conversation or join us on Twitter, Facebook, LinkedIn, and Threads. Let's stay connected!
To submit a correction request, please visit our Contact Us page.