Dyax Announces Completion of Biologics License Application for DX-88 for Hereditary Angioedema
Dyax Corp. announced the completion of its biologics License Application (BLA) with the U.S. food and Drug Administration (FDA) for approval of Dyax's lead product candidate DX-88 (ecallantide) for the treatment of hereditary angioedema (HAE). Dyax has requested Priority Review, which, if granted, would set a target date of six months from receipt of the completed submission for the FDA to take action on the application. Priority 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 final portion of the BLA, the clinical section, was based primarily on data from two Phase 3 clinical studies, EDEMA3(R) and EDEMA4(R), which 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.
The recombinant, small protein, DX-88, was discovered utilizing the Company's proprietary phage display technology. DX-88 is a potent and selective plasma kallikrein inhibitor, a key mediator of inflammation in angioedema, and is being evaluated as a subcutaneous therapy for treating acute HAE attacks.
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