Last week, the US Food and Drug Administration (FDA) announced the acceptance of an indication extension filing from Japan’s Eisai (TYO: 4523) for Leqembi (lecanemab), an amyloid-beta (Aβ)-targeting therapy intended as a once-monthly maintenance treatment for early Alzheimer’s disease (AD). Currently, the intravenous therapy has conditional approval in the United States for bi-weekly administration in patients experiencing mild cognitive impairment or mild dementia.
This submission is backed by modeled data derived from Phase II and III clinical trials, along with their respective open-label extension studies, demonstrating a significant reduction in Aβ plaques.
Leqembi is also approved in China and Japan and is under review in several additional markets.- Flcube.com
