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