The US Food and Drug Administration has granted priority review for ViroPharma's Cinryze C1 inhibitor (human) as a treatment for acute attacks of hereditary angioedema. The supplemental Biologics License Application, submitted to the agency on December 1, 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.
Cinryze was approved on October 10, 2008 for routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE, the company noted.
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