FDA extends sBLA review of Leqembi Iqlik
BioArctic’s partner Eisai has announced that the FDA has extended the review period by three months for the supplemental Biologics License Application (sBLA) for a once weekly lecanemab irmb subcutaneous injection, also known as Leqembi Iqlik, as a starting dose for the treatment of early Alzheimer’s disease.
May 11, 2026
The new Prescription Drug User Fee Act (PDUFA) action date is August 24, 2026.
Additional information
As part of the ongoing review process, the agency requested additional information and has determined that it constituted a major amendment to the sBLA, extending the PDUFA date to allow sufficient time for a full review of the additional materials. The FDA has not raised any concerns to date regarding the approvability of Leqembi Iqlik as a starting dose.
Eisai believes that the comprehensive clinical data package evaluating subcutaneous administration of Leqembi across multiple studies and dosing regimens strongly supports the potential use of Leqembi Iqlik for initiation therapy, following FDA approval of the subcutaneous maintenance dosing regimen on August 26, 2025.
Leqembi has been approved by more than 50 regulatory authorities worldwide, reflecting broad regulatory confidence in Leqembi as a treatment option for early Alzheimer’s disease.
Published: May 11, 2026
