BAX 855 is filed at FDA for treatment of Haemophilia A- Baxter

Baxter International Inc. has announced that the company has submitted a biologics license application (BLA) to the FDA for the approval of BAX 855, an investigational, extended half-life recombinant factor VIII (rFVIII) treatment for Haemophilia A based on ADVATE [Antihaemophilic Factor (Recombinant)]. The submission is based on positive results from a prospective, global, multi-centre, open-label, two-arm Phase III study of 137 previously treated patients (PTP). The results demonstrated that BAX 855 met its primary endpoint in the control and prevention of bleeding episodes and routine prophylaxis for patients who were 12 years or older. Patients in a twice-weekly prophylaxis arm experienced a 95 per-cent reduction in median ABR as compared to those in the on-demand arm (1.9 vs. 41.5, respectively). BAX 855 was also effective in treating bleeding episodes, 96 per-cent of which were controlled with one or two infusions. No patients developed inhibitors to BAX 855 and no treatment-related serious adverse events, including hypersensitivity, were reported. The most common (three patients) product-related adverse reaction was headache.

Baxter expects to present additional data from the BAX 855 pivotal trial in the coming months. The continuation study remains ongoing for patients who completed the pivotal trial and the Phase III study among previously treated patients under the age of 12 with severe Haemophilia A is progressing. Once the paediatric study is complete, Baxter expects to file for marketing authorization with the European Medicines Agency in 2016.