Sunday, February 04, 2007

Alphanate Approved for Clotting Disorder

(HealthDay News) -- The U.S. Food and Drug Administration has approved a biologic product called Alphanate for people with a bleeding disorder called von Willebrand disease (vWD) who require surgery.

People with vWD, the most common inherited bleeding disorder affecting about 1 percent of the U.S. population, have a missing or ineffective hormone called desmopressin. In most cases, people with the clotting disorder do not require treatment to stop bleeding after an injury or surgery, the FDA said.

But for some 2,000 people in the United States with moderate-to-severe forms of the disease, bleeding can be excessive if not treated.

Alphanate is made from purified human plasma that has been screened for blood-borne viruses, the agency said in a statement. But it conceded that transmission of certain viruses "while very low, cannot be totally eliminated."

Alphanate, made by Los Angeles-based Grifols Biologicals Inc., is already approved for other bleeding disorders including hemophilia A, the agency said.

More information
To learn more about vWD, visit the U.S. National Heart Lung and Blood Institute.

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