FDA Approves Octapharma’s wilate

The U.S. Food and Drug Administration (FDA) has approved wilate for the treatment of spontaneous and trauma-induced bleeding episodes in patients with all types of von Willebrand disease (VWD). Developed by Octapharma, the new highpurity, double-virus inactivated von Willebrand Factor/Coagulation Factor VIII Concentrate (Human) demonstrated efficacy for all types of VWD, including pediatric patients, in four prospective clinical trials utilizing both objective and subjective criteria.

VWD is the most common bleeding disorder and is found in approximately 1 percent to 2 percent of the U.S. population, according to the Centers for Disease Control and Prevention. The FDA approval of wilate marks the entrance of Octapharma USA into the U.S. blood coagulation market, with product availability scheduled for early 2010.