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
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