An official website of the United States government Here’s how you know

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

In this section: Vaccines

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

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

Top