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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 Au
About this update from Eisai Co., Ltd.
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