Posted by Michael Wonder on 07 Jan 2023
Eisai submits supplemental biologics license application to FDA for traditional approval of Leqembi (lecanemab-irmb) for the treatment of Alzheimer’s disease
7 January 2023 - Submission for traditional approval follows FDA accelerated approval of Leqembi on the same day, and is based on data from the confirmatory Phase 3 Clarity AD clinical trial.
Eisai and Biogen announced Eisai has submitted a supplemental biologics license application to the US FDA supporting the conversion of the accelerated approval of Leqembi (lecanemab-irmb) 100 mg/mL injection for intravenous use to a traditional approval.
