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Biogen, Eisai Get January 2025 FDA Action Date for Monthly Leqembi
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Eisai Initiates Rolling Biologics License Application to US FDA for LEQEMBI (Lecanemab-irmb) for Subcutaneous Maintenance Dosing for the Treatment of Early Alzheimer's Disease Under the Fast Track Status
Eisai Co., Ltd. announced today that Eisai has initiated the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb (U.S. brand name: LEQEMBI) subcutaneous autoinjector for weekly maintenance dosing after it was granted Fast Track designation by the FDA.
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