Hemgenix® (etranacogene dezaparvovec-drlb) – New orphan drug approval
November 22, 2022 - The FDA announced the approval of CSL Behring’s Hemgenix (etranacogene dezaparvovec-drlb), 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.
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