Humate-P Approved to Prevent Excessive Bleeding in Patients withvon Willebrand Disease Undergoing SurgeryStudies show efficacy, safety for surgical candidates with common bleeding disorder
KING OF PRUSSIA, Pa., April 30, 2007 /PRNewswire/ -- Humate-P(R) (Antihemophilic Factor/von Willebrand Factor Complex [Human]), CSL Behring's factor replacement therapy for the treatment of hemophilia A and von Willebrand disease (VWD), has been approved by the U.S. Food and Drug Administration (FDA) to prevent excessive bleeding during and after surgery, in patients with severe VWD and mild to moderate VWD where the use of desmopressin is known or suspected to be inadequate. The new indication approval follows the results of two separate clinical studies - one in Europe, another in the United States - that demonstrate the hemostatic efficacy and safety of Humate-P for VWD patients undergoing major, minor and oral surgical procedures.
"For individuals with VWD, the most common inherited bleeding disorder, even minor surgery can present serious risks and require special care," said Garrett E. Bergman, M.D., Senior Director Medical Affairs, U.S. Commercial Operations at CSL Behring. "Humate-P, which for years has been used successfully to treat spontaneous bleeding episodes in VWD patients, can now be administered to help prevent excessive bleeding in these patients during and after surgery."
In the U.S. clinical study, the safety and hemostatic efficacy of Humate-P were studied in 35 VWD patients undergoing surgery; in Europe, Humate-P was investigated in an additional 27 subjects. For each of the 62 patients, a pharmacokinetic assessment was performed several days before the surgical procedure to individualize the dosing of Humate-P. Across the studies, 44 of the 62 patients underwent surgeries that could be classified as major (including joint replacement, intracranial surgery, and hysterectomy). In 61 subjects, investigators classified the efficacy of Humate-P as either good or excellent. The most common adverse events in the clinical trials subjects were postoperative hemorrhage (35 events in 19 subjects), postoperative nausea, and postoperative pain.
In 1999, the FDA approved Humate-P for use in treating severe VWD and mild to moderate VWD where the use of desmopressin is known or suspected to be inadequate. Previously, it had been approved only for adult patients with hemophilia A.
About von Willebrand disease
Von Willebrand disease, the most common hereditary bleeding disorder in the United States, affects approximately 1 to 2% of the U.S. population. It is caused by a deficiency or abnormality of the von Willebrand factor, a protein in the blood that is necessary for normal blood clotting. Men and women are equally likely to be affected by VWD. VWD is classified by type of defect, ranging from Type I (the most common and mildest) to Type III (the least common and most severe).
Women with VWD are more likely than other women to experience heavy, prolonged menstruation. Other common symptoms of VWD include frequent nosebleeds and easy bruising. Bleeding can be mild or serious and can occur as a result of injury, or without an obvious cause. More serious symptoms include bleeding into joints and internal organs. An individual with any of the three types of VWD may require special care during dental procedures, surgery, and childbirth.
There is no "cure" for VWD, but different situations can be treated effectively in different ways. Specific treatments may include: desmopressin acetate, which, in patients with mild VWD, can release stored von Willebrand factor; von Willebrand factor replacement therapies such as Humate-P; and oral contraceptives, to reduce menstrual bleeding and to raise von Willebrand factor levels in the bloodstream.
Humate-P(R), Antihemophilic Factor/von Willebrand Factor Complex (Human) Dried, Pasteurized, is a factor replacement therapy with more than 19 years of demonstrated safety and efficacy around the world. After more than one-half billion units infused, there is no documented evidence of viral transmission with Humate-P. It is an injectable product that works by replacing the von Willebrand factor/factor VIII missing in patients with VWD. Humate-P contains the high molecular weight of multimers of von Willebrand factor important for correcting the coagulation defect in patients with VWD. The distribution of high molecular weight multimers in Humate-P corresponds closely to that found in normal human plasma.
Important Safety Information:
Antihemophilic Factor/von Willebrand Factor Complex (Human), Dried, Pasteurized, Humate-P(R) is indicated in adult patients for treatment and prevention of bleeding in hemophilia A (classical hemophilia). Humate-P is also in indicated in adult and pediatric patients with von Willebrand disease (VWD) for (1) treatment of spontaneous and trauma-induced bleeding episodes, and (2) prevention of excessive bleeding during and after surgery. This applies to patients with severe VWD, and patients with mild and moderate VWD for whom use of desmopressin is known or suspected to be inadequate.
Humate-P is contraindicated in individuals with a history of anaphylactic or severe systemic response to antihemophilic factor or von Willebrand factor preparations or to any of its components.
Thromboembolic events have been reported in VWD patients receiving coagulation factor replacement, especially in the setting of known risk factors for thrombosis. Caution should be exercised and antithrombotic measures considered.
Humate-P is derived from human plasma. As with all plasma-derived products, the risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.
Although few adverse reactions have been reported in patients receiving Humate-P, the most commonly reported are allergic-anaphylactic reactions, including urticaria, chest tightness, rash, pruritus, edema, shock, chills and fever, and hypervolemia. For patients undergoing surgery, the most common adverse reactions are postoperative wound or injection-site bleeding.
Please see full prescribing information for Humate-P at http://www.humatep.com.
About CSL Behring
CSL Behring is a global leader in the plasma protein biotherapeutics industry. Passionate about improving the quality of patients' lives, CSL Behring manufactures and markets a range of safe and effective plasma-derived and recombinant products and related services. The company's therapies are used in the treatment of immune deficiency disorders, hemophilia, von Willebrand disease, other bleeding disorders and inherited emphysema. Other products are used for the prevention of hemolytic diseases in the newborn, in cardiac surgery, organ transplantation and in the treatment of burns. The company also operates one of the world's largest plasma collection networks, ZLB Plasma. CSL Behring is a subsidiary of CSL Limited, a biopharmaceutical company with headquarters in Melbourne, Australia. For more information, visit http://www.cslbehring.com.
Media Contact: Sheila A. Burke Director, Public Relations & Communications Worldwide Commercial Operations CSL Behring 610-878-4209Sheila.Burke@cslbehring.com
CONTACT: Sheila A. Burke, Director, Public Relations & Communications,Worldwide Commercial Operations, of CSL Behring, +1-610-878-4209, or Sheila.Burke@cslbehring.com
Web site: http://www.cslbehring.com/
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Posted: April 2007