Eisai initiates rolling Biologics License Application to US FDA for Leqembi® (lecanemab-irmb) for subcutaneous maintenance dosing

BioArctic AB’s partner Eisai announced that they have initiated the rolling submission of a Biologics License Application to the U.S. Food and Drug Administration for lecanemab-irmb subcutaneous autoinjector for weekly maintenance dosing after it was granted Fast Track designation by the FDA.