Eisai (ESAIY) and Biogen (BIIB) announced that the U.S. Food and Drug Administration, FDA, has accepted for review Eisai’s Supplemental Biologics License Application, sBLA, for lecanemab-irmb subcutaneous autoinjector, SC-AI, LEQEMBI IQLIK, as a weekly starting dose. LEQEMBI is indicated for the treatment of Alzheimer’s disease, AD, in patients with Mild Cognitive Impairment, MCI, or mild dementia stage of disease. The sBLA has been granted Priority Review, with a Prescription Drug User Fee Act, PDUFA action date of May 24, 2026.
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