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New Gene Therapy Approval

On November 22, 2022, the FDA approved CSL Behring’s Hemgenix, a gene therapy for treatment of adults with hemophilia B (congenital Factor IX deficiency) who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes. Although hemophilia B is a rare condition, intravenous infusions to treat hemophilia B range from $550,000-$750,000 annually. Hemgenix is administered as a single dose intravenous infusion. Hemgenix will cost approximately $3.5 million, which will make it the most expensive medicine approved to date in the world for a single-use therapy.

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