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FDA Grants Priority Review of a Supplemental Biologics License Application for Cinryze(TM) C1 Inhibitor (Human) as Treatment for Acute Attacks of Hereditary Angioedema (HAE)
Date:2/3/2009

- PDUFA Date for Cinryze for Acute HAE Indication is June 3, 2009 -

EXTON, Pa., Feb. 3 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review for Cinryze C1 Inhibitor (human) as a treatment for acute attacks of Hereditary Angioedema (HAE). The supplemental Biologics License Application (sBLA), submitted to the FDA on December 1, 2008, was based on a re-analysis and resubmission of data from a pivotal Phase 3 acute treatment study of Cinryze and interim data from an ongoing open label acute study of the drug.

Cinryze was approved on October 10, 2008 for routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE.

Priority review is granted by the FDA for a treatment that addresses an unmet medical need and demonstrates improvement over existing therapies. The FDA expedites the approval process for applications granted priority review from ten to six months. The PDUFA date for the sBLA is June 3, 2009.

"The priority review designation marks a positive step in bringing another use of Cinryze closer to the patients who suffer acute attacks of hereditary angioedema," commented Vincent Milano, ViroPharma's president and chief executive officer. "We look forward to working with the FDA on approval so that we can help this additional group of patients."

The administration of Cinryze produced beneficial effects in treating acute HAE attacks in these studies. The safety profile was similar to that observed with the use of Cinryze for routine prophylaxis of angioedema attacks in patients with HAE, the currently approved indication. Overall, more than 9,000 doses of Cinryze have been administered to over 180 patients in all controlled and open
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SOURCE ViroPharma Incorporated
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