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