Baxter announced results from a Phase 3 clinical trial evaluating the safety, efficacy, and pharmacokinetics of BAX 111, a recombinant von Willebrand factor (rVWF) for the treatment of bleeding episodes in patients with von Willebrand disease.
The multicenter, open-label trial evaluated BAX 111 administered in combination with Advate or as a stand-alone therapeutic agent in the on-demand treatment of 37 patients with severe von Willebrand disease. The primary endpoint was the number of patients experiencing successful treatment for bleeding episodes.
The primary endpoint was met in this study with all patients achieving pre-specified success in the on-demand treatment of bleeding events (100%, 22 of 22 patients who experienced bleeds in the trial). Based on these results, Baxter intends to initiate a study of BAX 111 in a prophylaxis treatment setting before the end of the year.
Previously, the FDA had granted Orphan Drug designation to BAX 111 in November 2010. Baxter intends to file for approval in the U.S. before the end of 2014.
For more information call (800) 422-9837 or visit Baxter.com.