Baxter International has submitted an application in the US seeking approval of a new drug to treat the bleeding disorder haemophilia.
BAX-855, an extended-release form of the firm’s Advate (recombinant coagulation factor VIII), has shown in clinical trials a potent ability to reduce and prevent bleeds in patients with the genetic disorder.
According to Phase III data included in the US filing, patients in a twice-weekly prophylaxis arm experienced a 95% reduction in median bleeding rates compared to those in the on-demand arm (1.9 vs. 41.5, respectively).
But the drug was also highly effective in treating bleeding episodes in the trial, 96% of which were controlled with one or two infusions, the firm said.
Ticking safety boxes, no patients taking part developed inhibitors to BAX 855 and no treatment-related serious adverse events, including hypersensitivity, were reported.
Baxter said it plans to file to marketing authorisation in Europe in 2016 after an ongoing paediatric study with the drug is complete.