CHMP recommends Obizur (susoctocog alfa) for treatment of acquired haemophilia .- Baxalta
The CHMP recommends marketing authorisation for recombinant porcine Factor VIII Obizur (susoctocog alfa) from Baxalta for treatment of acquired haemophilia due to factor VIII antibodies, an orphan indication.
Comment: Approximately one-third of individuals with hemophilia A develop an immune reaction (inhibitors) to human FVIII (hFVIII) and can no longer respond to treatment with the coagulation factor. Current therapies, specifically human factor VIIa (NovoSeven) and FEIBA, work by bypassing the natural hemostatic pathway and forcing coagulation with much higher levels of FVIIa than normal. In contrast, OBI-1, (now Obizur) a recombinant form of porcine FVIII that typically possesses low cross reactivity to anti-hFVIII antibodies, is a replacement therapy, activating the natural hemostatic pathway. This should allow clinicians to correlate activity and efficacy with a biomarker, and therefore guide dosing to better predict treatment outcomes.
Obizur was FDA approved in October 2014.
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