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STN: BLA 125772
Proper Name: etranacogene dezaparvovec-drlb
Tradename:  HEMGENIX
Manufacturer: CSL Behring LLC

  • HEMGENIX is an adeno-associated virus vector-based gene therapy indicated for the 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.

Product Information

  • Package Insert - HEMGENIX
  • Demographic Subgroup Information – etranacogene dezaparvovec-drlb (HEMGENIX)
    Refer to Section 1.1 of the Clinical Review Memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.

Supporting Documents


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