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news.US-based biopharmaceutical company ViroPharma has announced that the FDA has granted priority review for Cinryze C1 inhibitor as a treatment for acute attacks of hereditary angioedema.
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The supplemental biologics license application (sBLA), submitted to the FDA in December 2008, was based on a re-analysis and resubmission of data from a pivotal Phase III acute treatment study of Cinryze and interim data from an ongoing open-label acute study of the drug.
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 10 to six months. The Prescription Drug User Fee Act date for the sBLA is June 3, 2009.
Cinryze was approved in October 2008 for routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema (HAE).
Vincent Milano, ViroPharma’s president and CEO, said: The priority review designation marks a positive step in bringing another use of Cinryze closer to the patients who suffer acute attacks of HAE. We look forward to working with the FDA on approval so that we can help this additional group of patients.