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FDA Approves Plasma Replacement Therapy for von Willebrand Disease NEW YORK -- January 13, 2009 -- The US Food and Drug Administration (FDA) has approved a high-purity, double virus inactivated von Willebrand Factor/Coagulation Factor VIII Concentrate (Human [Wilate]) for the treatment of spontaneous and trauma-induced bleeding episodes in patients with all types of von Willebrand disease (VWD). The double virus inactivated VWF/FVIII, high-purity concentrate is exclusively derived from large pools of human plasma collected in FDA approved plasma donation centres The FDA is based on 4 prospective clinical trials demonstrating the safety, tolerability, and haemostatic efficacy of the double virus inactivated VWF/FVIII, high-purity concentrate in the treatment of acute bleeding episodes and prophylaxis in patients with various types of VWD. Using objective criteria, the replacement therapy was observed in 1,068 bleeding episodes and determined to be successful between 84% and 93% of the time with results varying dependent on patient type. SOURCE: Octapharma E-mail this page to a friend or colleague! To print, use this version