Posted by Michael Wonder on 10 Jun 2024
FDA accepts filing of Leqembi (lecanemab-irmb) sBLA for IV maintenance dosing for the treatment of early Alzheimer's Disease
8 June 2024 - Eisai announced today that that the US FDA has accepted Eisai's supplemental biologics license application for less frequent monthly lecanemab-irmb (Leqembi) intravenous maintenance dosing.
A PDUFA action date is set for 25 January 2025.
