Posted by Michael Wonder on 03 Sep 2025
Rolling sBLA initiated to the US FDA for Leqembi Iqlik (lecanemab-irmb) as a subcutaneous starting dose for the treatment of early Alzheimer's disease under fast track status
3 September 2025 - BioArctic partner Eisai announced today that they have initiated a rolling submission of the supplemental biologics license application to the US FDA for Leqembi Iqlik (lecanemab-irmb) subcutaneous auto-injector, as a weekly starting dose after the FDA granted fast track status.
This submission follows the approval of Leqembi Iqlik for maintenance dosing in the US on 29 August 2025. If approved for initiation dosing, Leqembi Iqlik would be the first and only anti-amyloid treatment to offer at-home injection from the start to help patients and care partners to treat this progressive, deadly disease.
