Hemgenix FDA Approval History
FDA Approved: Yes (First approved November 22, 2022)
Brand name: Hemgenix
Generic name: etranacogene dezaparvovec-drlb
Dosage form: Suspension for Intravenous Infusion
Company: CSL Behring
Treatment for: Hemophilia B
Hemgenix (etranacogene dezaparvovec-drlb) is an adeno-associated virus vector-based gene therapy indicated for the treatment of adults with hemophilia B.
- Hemgenix is indicated for the treatment of adults with hemophilia B (congenital Factor IX deficiency) who currently use Factor IX prophylaxis therapy; or who have current or historical life-threatening hemorrhage; or who have repeated, serious spontaneous bleeding episodes.
- Hemgenix is administered as a single intravenous infusion and can be administered only once.
Development timeline for Hemgenix
Further information
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