Hereditary angioedema drug is approved

WASHINGTON, Oct. 13 (UPI) -- The U.S. Food and Drug Administration has approved for marketing the first product in the United States that protects people with hereditary angioedema.

The FDA said the disease, also known as HAE, is a rare and potentially life-threatening genetic disease that affects about 6,000 to 10,000 individuals in the United States.

The product, called Cinryze, is licensed for the prevention of HAE attacks, which can occur spontaneously or during stress, surgery, or infection in patients diagnosed with the disease. Attacks can produce rapid swelling of the hands, feet, limbs, face, intestinal tract or airway. Swelling of the larynx can lead to asphyxiation.

"Cinryze should greatly enhance treatment options for those with hereditary angioedema and potentially save lives," said Dr. Jesse Goodman, director of the FDA's Center for Biologics Evaluation and Research.

The federal agency said Cinryze is administered intravenously and can be used every three or four days for routine prevention of HAE attacks.

Cinryze is manufactured by Lev Pharmaceuticals Inc. of New York through a contract manufacturing agreement with the Sanquin Blood Supply Foundation in The Netherlands.