1 April 2024 - Eisai and Biogen announced today that Eisai submitted to the US FDA a supplemental biologics license application for monthly lecanemab-irmb (Leqembi) intravenous maintenance dosing.
The sBLA is based on modeling of observed data from the Phase 2 study (Study 201) and its open-label extension (OLE) as well as Clarity AD study (Study 301) and its OLE study.