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Cinryze "complete response" letter means HAE race is still on

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA's "complete response" letter to ViroPharma regarding its supplemental Cinryze filing for treatment of acute attacks of hereditary angioedema requests an additional clinical trial, stalling the firm's progress in a race with two other C1 esterase inhibitors to be the first acute HAE treatment approved in the U.S. ViroPharma said June 4 that FDA believes the placebo-controlled trial submitted in support of the sBLA "lacked robustness." Cinryze, which was first to market with a prophylaxis claim, is now in the same boat as CSL Behring's C1 esterase inhibitor Berinert: CSL received a "complete response" letter Dec. 5, 2008 requesting another trial. A filing for the third C1 candidate, Pharming's Rhucin, is expected in September. Pharming said March 31 that it is conducting additional data analyses at FDA's behest

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