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Humate-P Approved For Treatment Of Bleeding Episodes In Von Willebrand Disease KING OF PRUSSIA, PA -- June 4, 1999 -- The United States Food and Drug Administration has approved Centeon L.L.C.'s Humate-P(R) (antihemophilic factor/von Willebrand factor complex [human], dried, pasteurised) for the treatment of bleeding due to von Willebrand disease (vWD). Humate-P will also continue to be sold in the U.S. for the treatment of classical hemophilia (hemophilia A). Humate-P(R) will now be labelled with Factor VIII and Ristocetin Cofactor activity. Humate-P is indicated in adult patients for the treatment and prevention of bleeding in hemophilia A (classical hemophilia) and in adult and pediatric patients for treatment of spontaneous and trauma-induced bleeding episodes in severe von Willebrand disease, and in mild and moderate von Willebrand disease where use of desmopressin is known or suspected to be inadequate. Von Willebrand disease is the most common hereditary bleeding disorder, with a prevalence as high as one percent of the general population. Humate-P is the only von Willebrand factor replacement product on the U.S. market that is indicated for use with vWD patients. The ability of Humate-P to assist in the control of bleeding in patients with vWD was demonstrated by data from a pivotal study involving 46 vWD patients. Of the bleeding episodes experienced by adult patients who received Humate-P, at least 95 percent were reported to have an excellent or good response to Humate-P. Of the bleeding episodes in children with vWD who were treated with Humate-P, at least 93 percent were reported to have an excellent or good response to the treatment. In clinical trials with 97 patients, Humate-P was well tolerated with the following common side effects that included allergic reaction, uticaria, chest tightness, rash, pruritus and edema. Anaphylactic reactions may occur in very rare instances. As with all plasma-derived products, the risk of transmission of infectious agents, including viruses, cannot be completely eliminated. E-mail this page to a friend or colleague! To print, use this version