MONDAY, April 30, 2007 (HealthDay News) -- The U.S. Food and Drug Administration has approved a new therapy to prevent excessive bleeding during and after surgery in certain patients with von Willebrand disease (vWD). The disease is the most common inherited bleeding disorder, affecting about 1 percent of the U.S. population.
Humate-P is the second biological product to be approved for surgery and invasive procedures in patients with vWD who don't respond to the medication desmopressin. The first biological product, Alphanate, was approved by the FDA earlier this year. But, Humate-P is the first product specifically for patients with severe vWD who are undergoing major surgery, the agency said.
"This is an important advance for patients with vWD, including those who are severely affected by the disorder," said Dr. Jesse Goodman, 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."
Men and women are equally affected by vWD, which is caused by a deficiency or defect in certain plasma proteins critical to blood clotting.
Humate-P is manufactured by CSL Behring GmbH, in Marburg, Germany.
The FDA has more about this approval.