Baxter reports positive von Willebrand disease drug data

Baxter has announced positive topline results from a new clinical trial assessing the benefits of a new therapy for the inherited bleeding disorder von Willebrand disease.

The phase III study evaluated the safety, efficacy and pharmacokinetics of the von Willebrand factor BAX 111, which is the first recombinant treatment in clinical development for this condition.

It was able to meet its primary efficacy endpoint in the study, with all of the 37 patients achieving pre-specified success in the on-demand treatment of bleeding events. There were no reports of inhibitor development or thrombotic events in the study participants.

Both the European Commission and the US Food and Drug Administration have granted orphan drug designation to BAX 111. The company intends to file for US approval of the therapy before the end of the year.

Dr Bruce Ewenstein, vice-president of clinical affairs at Baxter BioScience, said: "With these findings, we have taken another significant step forward as we continue to expand on our increasingly broad pipeline of potential treatments to improve outcomes for patients with a range of bleeding disorders."

This comes after the firm also recently shared clinical data underlining the long-term efficacy of its drug Advate as a means of treating haemophilia A.