Posted by Michael Wonder on 06 Mar 2023
FDA accepts Eisai's filing of a supplemental biologics license application and grants priority review for traditional approval of Leqembi (lecanemab-irmb) for the treatment of Alzheimer's disease
5 March 2023 - Priority Review accelerates FDA review time with a PDUFA target action on 6 July 2023.
Eisai Co and Biogen announced today that the US FDA has accepted Eisai's supplemental biologics license application for Leqembi (lecanemab-irmb) 100 mg/mL injection for intravenous use, supporting the conversion of the accelerated approval of Leqembi to a traditional approval.
