Posted by Michael Wonder on 14 Jan 2025
FDA accepts Leqembi (lecanemab-irmb) biologics license application for subcutaneous maintenance dosing for the treatment of early Alzheimer’s disease
13 January 2025 - Eisai and Biogen announced today that the US FDA has accepted Eisai’s biologics license application for lecanemab-irmb (Leqembi) subcutaneous auto-injector for weekly maintenance dosing.
A PDUFA action date is set for 31 August 2025.
