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

• 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

Supporting Documents

• November 22, 2022 Approval Letter - HEMGENIX
• November 22, 2022 Summary Basis for Regulatory Action - HEMGENIX
• Approval History, Letters, Reviews, and Related Documents - HEMGENIX