Eisai to Apply to FDA for Preventative Use of Leqembi® (lecanemab) to Treat Alzheimer’s in 2026

Nikkei Asia reported that Eisai will apply to the FDA to expand the approval Leqembi® (lecanemab) to use for prevention of Alzheimer’s disease (AD) as soon as April 2026.  Clinical trials are in the final stages.  Leqembi® was co-developed by Eisai and Biogen.

Leqembi® was approved in Japan on 25 September 2023 and received traditional approval in the US to treat AD on 6 July 2023.