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FDA NEWS RELEASE

FOR IMMEDIATE RELEASE
P07-11
February 2, 2007

Media Inquiries:
Heidi Rebello, 301-827-6242
Consumer Inquiries:
888-INFO-FDA


FDA Approves New Product to Treat Von Willebrand Disease

The U.S. Food and Drug Administration (FDA) today announced the approval of Antihemophilic Factor/von Willebrand Factor Complex (Human), Alphanate. The product is approved for patients undergoing surgery or invasive procedures with von Willebrand disease (vWD) in whom the hormone desmopressin is either ineffective or contraindicated. It is not approved for patients with severe vWD (Type 3) who are undergoing major surgery. The disease is the most common inherited bleeding disorder, affecting about one percent of the U.S. population.

Alphanate is the first biologic product approved for treatment of surgical and invasive procedures in patients with vWD. Alphanate is already approved for the prevention and control of bleeding in patients with Factor VIII deficiency due to hemophilia A or acquired Factor VIII deficiency.

"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 Jesse L. Goodman, M.D., MPH, director of FDA's Center for Biologics Evaluation and Research.

Men and women are equally affected by vWD, which is caused by a deficiency or defect in certain plasma proteins critical to blood clotting. In most affected people, the disease is mild, and treatment usually is not required to stop bleeding. However, about 2,000 people in the U.S. each year suffer from moderate and severe forms of the disease in which bleeding can be excessive if not treated.

Successful management of surgery or invasive procedures in mildly, moderately and severely affected individuals routinely requires correction of the bleeding defect. In the absence of correction of the bleeding defect, patients may suffer from prolonged bleeding and delayed wound healing.

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, which are Factor VIII (also know as Antihemophilic factor) and von Willebrand factor. Alphanate undergoes two separate steps for viral inactivation to reduce the risk for transfusion-transmitted viruses. However, the potential risk for the transmission of blood-borne viruses, and theoretically variant CJD, while very low, cannot be totally eliminated.

In clinical studies with Alphanate, 120 major, moderate and minor surgical procedures were performed in 76 patients. Based on predefined criteria for efficacy, more than 90 percent of patients had favorable outcomes. In these clinical studies, 15.8 percent of subjects and 5.7 percent of infusions were accompanied by adverse reactions, most commonly itching, pharyngitis, paresthesia (a sensation of numbness and tingling on the skin) and headache, swelling of the face, and rash and chills.

Alphanate is manufactured by Grifols Biologicals, Inc., Los Angeles, Calif.

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