25 September 2023 - Eisai and Biogen announced today that humanised anti-soluble aggregated amyloid-beta monoclonal antibody “Leqembi intravenous infusion” (200 mg, 500 mg, lecanemab) has been approved in Japan as a treatment for slowing progression of mild cognitive impairment and mild dementia due to Alzheimer’s disease.
Leqembi's approval is based on Phase 3 data from Eisai’s large, global Clarity AD clinical trial, in which Leqembi met its primary endpoint and all key secondary endpoints with statistically significant results and confirmed the clinical benefit of Leqembi.