Sobi Reports EMA’s Validation of MAA for Efanesoctocog Alfa to Treat Haemophilia A
Shots:
- Efanesoctocog alfa's MAA has been accepted & validated by the EMA for haemophilia A of all ages. The application was based on the P-III study (XTEND-1) & (XTEND-Kids) paediatric study evaluating efanesoctocog alfa (qw) in 159 & 74 patients aged ≥12yrs. & <12yrs.
- The (XTEND-1) study met 1EPs & EPs and showed prevention of bleeds & superior bleed protection over prior prophylaxis along with improvements in physical health, pain & joint health. In (XTEND-Kids) paediatric study, the trial met 1EPs with no factor VIII inhibitors detected confirming the safety profile of efanesoctocog alfa
- Efanesoctocog alfa, a novel & investigational recombinant factor VIII therapy was approved in the US as ALTUVIIIO in 2023
Ref: PRnewswire | Image: Sobi
Related News:- Sobi to Acquire CTI BioPharma for ~$1.7B
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