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FDA Advisory Committee Favors Approval of DX-88 for Acute Attacks of Hereditary Angioedema

06 Feb 2009 - Dyax Corp. announced that the U.S. Food and Drug Administration’s (FDA) Pulmonary-Allergy Advisory Committee voted (6 yes, 5 no, 2 abstentions) in favor of approval of DX-88 (ecallantide) for the treatment of acute attacks of hereditary angioedema (HAE). If approved, DX-88 will be the first drug available in the U.S. for treating acute attacks of HAE and the first subcutaneously administered HAE therapy.
 
HAE is a rare, potentially fatal genetic disorder characterized by spontaneous episodes of severe, debilitating and often painful swelling. The Committee’s findings will be weighed by the FDA in determining whether DX-88 is to be approved for marketing.
 
The BLA submission was based primarily on data from two placebo-controlled Phase 3 clinical studies, known as EDEMA3 and EDEMA4, which, taken together, represent the largest placebo-controlled evaluation of any therapy used in the treatment of HAE.