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Sobi and Sanofi Report Results of Efanesoctocog Alfa (BIVV001) in P-III (XTEND-1) study for the Treatment of Haemophilia A

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Sobi and Sanofi Report Results of Efanesoctocog Alfa (BIVV001) in P-III (XTEND-1) study for the Treatment of Haemophilia A

Shots:

  • The P-III (XTEND-1) study evaluates the safety, efficacy & PK of efanesoctocog alfa (qw) in 159 patients aged ≥12yrs. with sev. haemophilia A prior treated with factor VIII replacement therapy
  • The study met its 1EPs & 2EPs i.e., the therapy showed prevention of bleeding episodes @52wks. In 2EPs, the therapy showed superiority in the prevention of bleeding episodes compared to prior prophylactic factor VIII replacement therapy, reduction in ABR, was well-tolerated & inhibitor development to factor VIII was not observed
  • The company will submit the results to regulatory authorities globally in 2022 while the submission in the EU from the ongoing (XTEND-Kids) paediatric study is expected in 2023

Ref: PR Newswire | Image: Sobi

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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