The P-III study (XTEND-Kids) evaluated the safety, efficacy, and PK of Altuviiio (50IU/kg, qw for 52wk.) in prior treated 75 patients aged <12yrs. with sev. hemophilia A. The 1EPs of the study were the occurrence of inhibitor development
The trial met its 1EPs with no factor VIII inhibitors detected & confirming the safety profile of efanesoctocog alfa in prior treated patients under 12yrs. of age
Altuviiio is a high-sustained FVIII therapy & has been approved in the US for routine prophylaxis, on-demand treatment and control of bleeding episodes, and perioperative management of bleeding in adults and children in Feb 2023; BTD from the US FDA in May 2022; FTD in Feb 2021 and ODD in 2017 while ODD from the EC in June 2019
Ref: Globenewswire | Image: Sanofi
Related News:- Sanofi’s Altuviiio Receives the US FDA’s Approval for the Treatment of Hemophilia A
