FDA approval for Cinryze for hereditary angioedema

On October 10, 2008, the U.S. Food and Drug Administration (FDA) approved for marketing the first product in the United States intended to protect people with hereditary angioedema (HAE), a rare and potentially life-threatening genetic disease. HAE affects about 6,000 to 10,000 individuals in the United States. The product, called Cinryze, given intravenously, is licensed for the prevention of HAE attacks. During an attack, swelling of body parts such as hands, feet, face, arms, or legs occurs. Swelling of the airway may cause difficulty swallowing or difficulty breathing, which can be life-threatening. According to the FDA, in clinical trials Cinryze was effective in preventing or decreasing the frequency of attacks in most but not all HAE patients.

• Learn more about hereditary angioedema
• FDA press release about Cinryze approval