The U.S. Food and Drug Administration (FDA) on Feb, 2 announced it had approved the marketing of biologic drug Alphanate for treatment of some patients with congenital von Willebrand Disease (vWD) in connection with surgery or other invasive procedures.

While Alphanate becomes the first biologic drug approved for treatment of surgical and invasive procedures in patients with vWD in whom the hormone desmopressin is either ineffective or contraindicated, the FDA said it was not approved for patients with severe vWD (Type 3).

Alphanate has been used for a decade to prevent and control of bleeding in patients with Factor VIII deficiency due to hemophilia A or acquired Factor VIII deficiency.

Von Willebrand Disease is the most common inherited bleeding disorder, affecting an estimated one to two percent of the U.S. population. It is caused by a deficiency or defect in certain plasma proteins critical to blood clotting.

Alphanate is purified from pooled human plasma from carefully screened and tested U.S. donors, and contains the clotting proteins deficient or defective in vWD.

"This approval is an important advance for patients and their surgeons, providing them access to a proven preventive therapy that can make needed surgery possible and safer," said Dr. Jesse L. Goodman, director of FDA's Center for Biologics Evaluation and Research.

Alphanate is manufactured by Grifols Biologicals, Inc. of Los Angeles, which acquired the product license for Alphanate in 2003 from AlphaTherapeutic Corporation.