ROCKVILLE, MD -- April 30, 2007 -- The FDA has approved Humate-P (Antihemophilic Factor/von Willebrand Factor Complex) for the prevention of excessive bleeding during and after surgery in certain patients with mild to moderate and severe von Willebrand disease (vWD). The disease is the most common inherited bleeding disorder, affecting about 1% of the U.S. population.
Humate-P is the second biological product to be approved for the management of surgery and invasive procedures in patients with vWD in whom the medication desmopressin may not work. The first biological product, Alphanate, was approved by FDA in February. However, Humate-P is the first product specifically for patients with severe vWD who are undergoing major surgery.
"This is an important advance for patients with vWD, including those who are severely affected by the disorder," said Jesse Goodman, MD, MPH, director of FDA's Center for Biologics Evaluation and Research. "Humate-P provides a preventive therapy that can make needed surgery not only possible, but also safer."
The product was originally approved for use in adult patients to treat and prevent bleeding from hemophilia A. It was later approved to treat spontaneous and traumatic bleeding for severe vWD and for mild and moderate vWD when desmopressin use is known or suspected to be inadequate.
Humate-P is made by purification of the needed clotting protein from human plasma from carefully screened and tested U.S. donors. It undergoes steps to further reduce the risk for transfusion-transmitted diseases. While the risk for the transmission of bloodborne diseases is very low, it can not be eliminated.
FDA based its approval on a clinical study of Humate-P in 35 patients suffering from vWD who underwent a total of 28 major and seven minor surgical procedures. The product was judged excellent or good in 91% of the patients who avoided severe hemorrhage. The most common adverse reaction following surgery was hemorrhage, in 30% of the patients; however, only 9% of the hemorrhages were classified as severe. Other adverse reactions in patients following surgery included nausea (24%) and pain (17%).
Men and women are equally affected by vWD, which is caused by a deficiency or defect in certain plasma proteins critical to blood clotting. In most cases, the disease is mild, and treatment usually is not required to stop bleeding. However, about 2,000 people in the United States each year suffer from moderate and severe forms of the disease in which bleeding can be excessive if not treated and possibly cause delayed wound healing.
Humate-P is manufactured by CSL Behring GmbH, Marburg, Germany.
SOURCE: FDA
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