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First Gene Therapy for Hemophilia B, CSL's HEMGENIX®, Approved by the European Commission

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 .

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uniQure Inc.: uniQure announces the European Commission approval of the first gene therapy for adults with hemophilia B

~ Historic approval represents the first gene therapy in Europe to treat hemophilia B and provides a new treatment option for patients that reduces the rate of annual bleeds, reduces or eliminates the

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Europe Approves First Gene Therapy for Hemophilia B

The European Commission has approved etranacogene dezaparvovec (Hemgenix), the first gene therapy for severe and moderately severe hemophilia B (congenital factor X1 deficiency).

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