FDA Approves Product To Treat Common Bleeding Disorder
von Willebrand disease treatment
The U.S. Food and Drug Administration approved Humate-P 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 percent 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 von Willebrand disease in whom the medication desmopressin may not work. The first biological product, Aphanate, was approved by FDA in February. However, Humate-P is the first product specifically for patients with severe von Willebrand disease 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, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research.