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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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
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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
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