Posted by Michael Wonder on 15 May 2024
Eisai initiates rolling biologics license application to US FDA for Leqembi (lecanemab-irmb) for subcutaneous maintenance dosing
15 May 2024 - BioArctic's partner Eisai announced today that they have initiated the rolling submission of a biologics license application to the US FDA for lecanemab-irmb (Leqembi) subcutaneous auto-injector for weekly maintenance dosing after it was granted fast track designation by the FDA.
The biologics license application is based on data from the Phase 3 Clarity AD open-label extension study, and modeling of observed data.
