LEV Pharma's Cinryzeâ„¢ Got FDA Marketing Approval For HAE

Filed in archive FDA Approvals , Treatment on October 12, 2008

A rare genetic and life threatening disease, hereditary angioedema (HAE) is an autosomal dominant disorder of C1 inhibitor (C1-INH) deficiency manifested by painless, nonpruritic, nonpitting swelling of the skin.

Now, LEV Pharma's Cinryzeâ„¢ has been given marketing approval for the protection of people with HAE.

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 is a C1-esterase inhibitor product derived from human plasma. This plasma protein regulates clotting and inflammatory reactions that, when impaired, can lead to local tissue swelling. C1-esterase inhibitor is low or does not function properly in individuals with HAE. In clinical trials, Cinryze was effective in preventing or decreasing the frequency of attacks in most but not all HAE patients. Adverse reactions reported in the study were considered mild or moderate in severity.

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