FDA panel to discuss Dyax' angiodema drug
US Food and Drug Administration's Pulmonary-Allergy Drugs Advisory Committee will meet to discuss Dyax' Biologics License Application for DX-88 (ecallantide) in the treatment of acute attacks of hereditary angiodema next month.
The submission was based primarily on data from two placebo-controlled Phase III trials, known as EDEMA3 and EDEMA4. In those studies, DX-88 demonstrated statistically-significant improvements over placebo in both the primary and secondary endpoints and was found to be well tolerated.
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