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Humate-P® Receives FDA Approval for Additional Use

The Food and Drug Administration (FDA) approved Humate-P®, a plasma-derived factor VIII/von Willebrand factor product, for the prevention of excessive bleeding during and after surgery in certain patients with mild to moderate and severe von Willebrand disease (VWD). Humate-P® is manufactured by CSL Behring, a global pharmaceutical company with corporate headquarters in King of Prussia, PA.

Humate-P® is the second human-derived factor product to be approved for the management of surgery and invasive procedures in patients with VWD in whom the synthetic drug desmopressin may not be effective. The first product, Grifols’ Alphanate®, received FDA approval in February 2007. The primary difference is that Humate-P® received FDA approval for another indication--surgery in patients with severe VWD, such as those with type 3.

In 1999, Humate-P® became the first biologic to be approved for use by the FDA in severe VWD patients. “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.”

Read the FDA release.

Source: FDA news release dated April 27, 2007