HEMGENIX
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
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