Adynovate: Additional Phase II/III data

Additional data from the open-label, international Phase II/III PROLONG-ATE trial in 137 patients ages 12-65 with previously treated severe hemophilia A showed that BAX 855 controlled 95.9% of all bleeding episodes with 1-2 infusions at a median dose of 29 IU/kg per infusion. Additionally, BAX 855 was rated “excellent” or “good” for 96.1% of bleeding episodes. Furthermore, twice-weekly BAX 855 as prophylaxis for 6 months led to no bleeds in 39.6% of compliant patients. Patients were treated prophylactically or on demand. Data were published in Blood. Baxalta previously reported top-line data from the trial showing that BAX 855 as prophylaxis for 6 months met the primary endpoint of reducing median ABR vs. on-demand treatment with BAX 855 (1.9 vs. 41.5, p<0.0001) (see BioCentury, Sept. 1, 2014). ...