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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.

Development timeline for Hemgenix

Nov 22, 2022Approval FDA Approves Hemgenix (etranacogene dezaparvovec-drlb) Gene Therapy for Hemophilia B
May 24, 2022FDA Accepts CSL Behring’s Biologics License Application for Etranacogene Dezaparvovec for Priority Review
Dec  9, 2021uniQure and CSL Behring Announce Primary Endpoint Achieved in HOPE-B Pivotal Trial of Etranacogene Dezaparvovec Gene Therapy in Patients with Hemophilia B
Oct 31, 2019uniQure Announces Publication of Positive Interim Data from Phase IIb Clinical Trial of Etranacogene Dezaparvovec

Further information

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