Update on FDA Priority Review of LEQEMBI® IQLIK™ (lecanemab-irmb) Subcutaneous Injection as a Starting Dose for Early Alzheimer’s Disease

TOKYO and CAMBRIDGE, Mass., May 08, 2026 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period by three months for the supplemental Biologics License Application (sBLA) for a once-weekly lecanemab-irmb subcutaneous injection (U.S. 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. Eisai and Biogen 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 more than 50 regulatory authorities worldwide, reflecting broad regulatory confidence in LEQEMBI as a treatment option for early Alzheimer’s disease. Eisai and Biogen 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. INDICATION LEQEMBI ® is indicated for the treatment of Alzheimer’s disease (AD). Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment (MCI) or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.

The release as fetched from its publisher. biogen.com ↗