HEMGENIX® underscores CSL's promise to deliver life-changing innovations that have the potential to help patients lead full lives
MARBURG, Germany, Feb. 20, 2023 /PRNewswire/ -- Global biotechnology leader CSL (ASX: CSL) today announced that the European Commission has granted conditional marketing authorization (CMA) for HEMGENIX® (etranacogene dezaparvovec), the first and only one-time gene therapy for the treatment of severe and moderately severe hemophilia B (congenital Factor IX deficiency) in adults without a history of Factor IX inhibitors. In the ongoing clinical trial, HEMGENIX® reduced the rate of annual bleeds with a single infusion by delivering a functional gene that acts as a blueprint for coagulation Factor IX, a protein important for blood clotting.1 It is the first approved gene therapy for hemophilia B in the European Union (EU) and European Economic Area (EEA).
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