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uniQure and CSL Behring Report Results of P-III (HOPE-B) Trial of Etranacogene Dezaparvovec for the Treatment of Hemophilia B

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uniQure and CSL Behring Report Results of P-III (HOPE-B) Trial of Etranacogene Dezaparvovec for the Treatment of Hemophilia B

uniQure and CSL Behring Report Results of P-III (HOPE-B) Trial of Etranacogene Dezaparvovec for the Treatment of Hemophilia B

Shots:

  • The P-III (HOPE-B) trial evaluates the safety & efficacy of etranacogene dezaparvovec vs FIX prophylactic therapy in 54 patients with hemophilia B
  • The trial achieved the pre-specified 1EPs of non-inferiority in ABR @18mos. over baseline FIX prophylactic therapy. The 2EPs showed a reduction in ABR, stable & durable FIX levels with mean FIX activity of 36.9% in the study population as measured by one-stage APTT-based clotting assay @18mos. post-infusion compared to FIX activity of 39.0% @6mos., was well-tolerated
  • Etranacogene dezaparvovec received the BTF from the US FDA & access to a PRIME regulatory initiative by EMA. CSL Behring plans for regulatory submissions in the US & EU in H1’22

Ref: Globe Newswire | Image: uniQure 

Click here to­ read the full press release 

Tuba

Tuba was Senior Editor at PharmaShots. She was curious, creative, and passionate about recent updates and innovations in the life sciences industry. She covered Biopharma, MedTech, and Digital health segments. Tuba also had an experience in digital and social media marketing and ran the campaigns independently. She can be contacted at connect@pharmashots.com.

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