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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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