Eisai initiates rolling Biologics License Application to US FDA for Leqembi® (lecanemab-irmb) for subcutaneous maintenance dosing
Stockholm, Sweden, May 15, 2024 – BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that they have 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. In the US, Leqembi is indicated for the treatment of Alzheimer’s disease (AD) in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease (collectively referred to as