FDA Accepts Filing and Grants Priority Review for Dyax' DX-88 for Hereditary Angioedema
Dyax Corp. announced that the U.S. food and Drug Administration (FDA) has accepted for filing the Company's biologics License Application (BLA) for DX-88 (ecallantide) for the treatment of acute attacks of hereditary angioedema (HAE) and has designated the application for Priority Review. Based on this designation, the FDA Prescription Drug User Fee Act (PDUFA) target action date is March 23, 2009, or six months from the BLA submission date of September 23, 2008. Priority Review designation is intended for those products that address unmet medical needs. DX-88 has previously been granted Orphan Drug Designation as well as Fast Track status by the FDA.
"The FDA's decision to grant Priority Review underscores the urgent need to address the treatment of acute attacks of hereditary angioedema," commented Henry E. Blair, Chairman, President and Chief Executive Officer of Dyax. "We are pleased to have received this designation and will continue to work closely with the FDA throughout the review period. This is an exciting milestone for Dyax, as it brings us one step closer to helping patients who have no therapeutic option approved for acute attacks of this potentially life-threatening condition."
The BLA submission is based primarily on data from two placebo-controlled Phase 3 clinical studies, EDEMA3 and EDEMA4, which, taken together, represent the largest placebo-controlled evaluation of any therapy used in the treatment of HAE. In these studies, DX-88 demonstrated statistically significant improvements over placebo in both the primary and secondary endpoints.
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