On Jan. 6, 2023, the U.S. Food and Drug Administration approved Leqembi (lecanemab-irmb) via the Accelerated Approval pathway for the treatment of Alzheimerﾒs disease. Leqembi is the second of a new category of medications approved for Alzheimerﾒs disease that target the fundamental pathophysiology of the disease.

Researchers evaluated Leqembiﾒs efficacy in a double-blind, placebo-controlled, parallel-group, dose-finding study of 856 patients with Alzheimerﾒs disease. The approval of Leqembi was granted to Eisai R&D Management Co.