MONDAY, April 30 (HealthDay News) -- The U.S. Food and Drug Administration has approved Humate-P (Antihemophilic Factor/von Willebrand Factor Complex) to help prevent excessive bleeding in patients with von Willebrand disease who are undergoing surgery.
The drug, manufactured by CSL Behring GmbH of Marburg, Germany, is made from a purified clotting protein collected from human plasma and is already approved for use in adult hemophilia patients.
Humate-P was approved for von Willebrand patients on the basis of a trial of 35 patients who underwent surgery. About 30 percent of patients did experience hemorrhages, but the hemorrhage was severe in only 9 percent of cases. The drug was considered good or excellent in 91 percent of patients without severe hemorrhage, and the most common side effects were nausea, which occurred in 24 percent of patients, and pain, which was reported in 17 percent.
"This is an important advance for patients with von Willebrand disease, including those who are severely affected by the disorder," said Jesse Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research, in a statement. "Humate-P provides a preventive therapy that can make needed surgery not only possible, but also safer."
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