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Cinryze Launch Plans Bear Hallmarks Of Successful Orphan Strategies

Executive Summary

ViroPharma/Lev scored a regulatory success with FDA's approval of Cinryze (C1 esterase inhibitor) for prophylaxis of hereditary angioedema. Now the firm needs to concentrate on turning that into a commercial success - and with the launch plans recently laid out, the firm seems poised to do that

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Overcoming an FDA advisory committee that expressed doubts about efficacy and potential hypersensitivity reactions and a "complete response" letter asking for a Risk Evaluation and Mitigation Strategy, Dyax won approval for Kalbitor (ecallantide) Nov. 27 to treat acute attacks of hereditary angioedema in patients 16 and older

Berinert Claims Another Part Of The HAE Orphan Market, But May Leave Room

FDA's approval of CSL Behring's Berinert for treatment of acute attacks of hereditary angioedema specifically mentions only two types of attacks. By approving the C1 esterase inhibitor with a targeted indication, the agency could be leaving open a window in the orphan exclusivity for another approval

Berinert Claims Another Part Of The HAE Orphan Market, But May Leave Room

FDA's approval of CSL Behring's Berinert for treatment of acute attacks of hereditary angioedema specifically mentions only two types of attacks. By approving the C1 esterase inhibitor with a targeted indication, the agency could be leaving open a window in the orphan exclusivity for another approval

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