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
