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

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

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  • The P-III (XTEND-1) study evaluated efanesoctocog alfa (qw) in 159 adults & adolescents aged ≥12yrs. with sev. haemophilia A prior treatment with factor VIII replacement therapy
  • The study met its 1EPs & 2EPs i.e., the therapy showed clinical bleed protection, median & mean ABR were 0.00 & 0.71. In the 2EPs, superior bleed protection with an ABR reduction of 77% & a mean ABR of 0.69 vs 2.96 on prior prophylaxis, mean factor VIII levels remained in the normal to near-normal range (>40 IU/dL) & 15 IU/dL @7 Day post-dose that increased factor activity level protection
  • The therapy also showed significant & clinical improvements in physical health, pain intensity & joint health, 96.7% of bleeds were resolved with a single 50 IU/kg dose

Ref: GlobalNewswire | Image: Sanofi

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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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