BAX 111: Phase III data
Top-line data from an open-label, international Phase III trial in 37 patients with severe hereditary vWD showed that on-demand treatment with IV BAX 111 given with or without Advate octocog alfa met the primary endpoint of the number of patients with treatment success for treated bleeding episodes, defined as a mean efficacy rating score of <2.5 points on a 4-point scale. Specifically, on-demand treatment with BAX 111 led to treatment success in 100% of the 22 patients who experienced bleeds during the trial. There were no reports of inhibitor development or thrombotic events. The most common adverse events were headache, vomiting/nausea and anemia, which were not considered to be related to treatment. There was 1 treatment-related serious adverse event characterized by chest discomfort and increased heart rate during infusion. ...