Fresh off of completing its spinout from Baxter, Baxalta has unveiled the positive data it’s using to back an approval for BAX 855, a long-acting factor VIII-replacement therapy that’s designed to do a better job at producing blood clots for haemophilia A patients.
The drug’s twice-weekly dosing schedule produced a half-life extension of 1.4- to 1.5-fold compared with Advate, the older Baxalta drug it’s designed to replace as the leaders in haemophilia scramble to field new and better drugs. Provided the FDA delivers an approval, the therapy will be sold as Adynovate.
Patients in the twice-weekly arm of the trial demonstrated a 95% reduction in median annualized bleed rate compared with the on-demand arm (1.9 vs. 41.5, respectively). BAX 855 was also effective in treating all bleeding episodes, 95.9% of which were controlled with one or two infusions at a median dose of 29.0 IU/kg per infusion. go to baxter.com