Eisai and Biogen recently announced that the US Food and Drug Administration (FDA) has extended the review period by 3 months for the supplemental Biologics License Application (sBLA) for a once?weekly lecanemab?irmb subcutaneous injection (US brand name: LEQEMBI IQLIK) as a starting dose for the treatment of early Alzheimer's disease. The new Prescription Drug User Fee Act (PDUFA) action date is August 24, 2026. 

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.

The companies believe 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 over 50 regulatory authorities worldwide, reflecting broad regulatory confidence in LEQEMBI as a treatment option for early Alzheimer's disease.

The companies look forward to ongoing discussions with the FDA as the review progresses, and are committed to bringing this important advancement to patients and care partners as quickly as possible to provide greater flexibility and choice in how anti-amyloid treatment is delivered.