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news.The FDA has approved CSL Behring's Humate-P, a drug to prevent excessive bleeding during and after surgery in patients with von Willebrand disease.
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Von Willebrand disease (vWD) is the most common inherited bleeding disorder, affecting about 1% of the US population. 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, 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.