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uniQure’s Hemgenix (etranacogene dezaparvovec-drlb) Receives the US FDA’s Approval for the Treatment of Hemophilia B

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uniQure’s Hemgenix (etranacogene dezaparvovec-drlb) Receives the US FDA’s Approval for the Treatment of Hemophilia B

Shots:

  • The US FDA has approved Hemgenix (etranacogene dezaparvovec-drlb) in adults aged ≥18yrs. with hemophilia B
  • The approval was based on the P-III (HOPE-B) trial evaluating Hemgenix (2x1013 gc/kg, IV) in 54 patients which showed a reduction in the rate of annual bleeds & 94% of patients discontinued factor IX prophylaxis and remained prophylaxis-free with mean factor IX activity of 39% @6mos. and 36.7% @24mos. post-infusion, 54% reduction in ABR bleeds over 6mos. on factor IX prophylactic replacement therapy
  • Under the terms of the agreement, CSL gets an exclusive right globally to Hemgenix in May 2021 & responsible for the development, registration & commercialization of the therapy

Ref: Globenewswire | Image: uniQure

Click here to­ read the full press release 

Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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