Eisai Co. (ESAIY) and Biogen (BIIB) announced that Eisai has completed the rolling submission of the Supplemental Biologics License Application to the U.S. FDA for Leqembi Iqlik as a weekly starting dose after the FDA granted Fast Track Status. Leqembi is indicated for the treatment of Alzheimer’s disease in patients with Mild Cognitive Impairment or mild dementia stage of disease. Upon acceptance of the sBLA, the FDA will set a Prescription Drug User Fee Act action date.
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