EXTON, Pa., May 18 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM) was honored with a Corporate Award at the National Organization for Rare Disorders (NORD) Annual Gala for its work in bringing Cinryze(TM) (C1 esterase inhibitor (human)) to market for a rare and devastating disorder -- hereditary angioedema (HAE).
HAE is a rare, severely debilitating, life-threatening genetic disorder caused by a deficiency of C1 inhibitor, a human plasma protein. Patients with C1 inhibitor deficiency experience recurrent, unpredictable, debilitating, and potentially life threatening attacks of swelling affecting the larynx, abdomen, face, extremities and urogenital tract. There are estimated to be at least 4,600 people with HAE in the United States.
'We are honored to be recognized by NORD for our work in bringing Cinryze to HAE patients in the U.S.,' said Vincent Milano, ViroPharma's president and chief executive officer, 'but what is even more gratifying for everyone at ViroPharma is making a difference in the lives of HAE patients who have literally been waiting for decades for this therapy.'
Cinryze (C1 esterase inhibitor (human)) was approved by the U.S. Food and Drug Administration in October 2008 for routine prophylaxis against HAE attacks in adults and adolescents. In February 2009, ViroPharma was granted priority review of a supplemental Biologics License Application for Cinryze for the treatment of acute attacks of HAE. If approved, Cinryze may be the first C1 esterase inhibitor available for the acute treatment for this condition. ViroPharma's Prescription Drug User Fee Act (PDUFA) date for the use of Cinryze for acute attacks in patients with HAE is June 3, 2009.
The NORD Gala is an annual event at which researchers and others are honored for significant achievements to improve the lives of people with rare diseases. NORD represents the nearly 30 million Americans who have rare diseases.
About Cinryze(TM) (C1 esterase inhibitor (human))
Cinryze is a highly purified, pasteurized and nanofiltered plasma-derived C1 esterase inhibitor product that has been approved by FDA for routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE. C1 inhibitor therapy has been used acutely for more than 35 years in Europe to treat patients with C1 inhibitor deficiency.
Cinryze has been generally well tolerated. The most common adverse reactions observed have been upper respiratory infection, sinusitis, rash and headache. No drug-related serious adverse events (SAEs) have been observed in clinical trials.
