Posted by Michael Wonder on 27 Jan 2026
FDA accepts Leqembi Iqlik (lecanemab-irmb) supplemental biologics license application as a subcutaneous starting dose for the treatment of early Alzheimer’s disease under priority peview
26 January 2026 - Eisai and Biogen announced today that the US FDA has accepted for review Eisai’s supplemental biologics license application for lecanemab-irmb (Leqembi) subcutaneous auto-injector, Leqembi IQLIK, as a weekly starting dose.
Leqembi is indicated for the treatment of Alzheimer’s disease (AD) in patients with mild cognitive impairment or mild dementia stage of disease (collectively referred to as early AD).
The sBLA has been granted priority review, with a PDUFA action date of 24 May 2026.
