BRIEF—Octapharma seeks FDA approval for wilate

The US subsidiary of Swiss biotech firm Octapharma has submitted a Biologics License Application Supplement (sBLA) to the US Food and Drug Administration (FDA) to expand the approval of wilate, von Willebrand Factor/Coagulation Factor VIII Complex (Human) lyophilized powder for solution for intravenous injection, to include routine prophylaxis to reduce the frequency of bleeding episodes in children and adults with any type of von Willebrand disease (VWD).

The application is supported by the results of Octapharma’s WIL-31 study, a prospective, non-controlled, international, multicenter Phase III trial that investigated the efficacy and safety of wilate prophylaxis over 12 months in people of age six and older with severe VWD of any type except type 2N.

Researchers reported an 84% reduction in ABR compared with on-demand treatment during the prior study. The median spontaneous ABR decreased by 95%. No serious drug-related adverse events or thrombotic events occurred during prophylaxis with wilate.

VWD is the most common bleeding disorder, found in up to 1% of the US population.