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Dyax Receives “Complete Response” For HAE Drug; REMS Will Be Required

Executive Summary

Dyax is joining a growing group of companies that have seen their approvals delayed, via a "complete response" letter, to work out a Risk Evaluation and Mitigation Strategy. The Cambridge, Mass. biotech got such a letter March 26 for ecallantide, its drug to treat acute attacks of hereditary angioedema

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Dyax Kalbitor Is Third To Market For HAE, But First For All Acute Attacks

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

Dyax Kalbitor Is Third To Market For HAE, But First For All Acute Attacks

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

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