Posted by Michael Wonder on 26 Nov 2025
Eisai completes rolling submission to US FDA for Leqembi Iqlik (lecanemab-irmb) supplemental biologics license pplication as a subcutaneous starting dose for the treatment of early Alzheimer's disease under fast track status
25 November 2025 - Eisai and Biogen announced today that Eisai has completed the rolling submission of the supplemental biologics license application to the US FDA for lecanemab-irmb (US brand name: Leqembi) subcutaneous auto-injector, Leqembi Iqlik, as a weekly starting dose after the FDA granted fast track atatus.
The supplemental biologics license application is supported by data evaluating subcutaneous administration of lecanemab across a range of doses and as part of sub-studies within the Phase 3 Clarity AD open-label extension following the 18 month core study in individuals with early Alzheimer's disease.
