Dyax Corp announced the completion of its Biologics License Application (BLA) with the US 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 and Edema4, 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 submission of the DX-88 BLA is a major milestone for Dyax," commented Henry E Blair, chairman, president and chief executive officer of Dyax. "We believe DX-88, a recombinant, subcutaneously administered therapy, has many characteristics that match well with the needs of HAE patients and physicians for a therapeutic option. We look forward to working with the FDA to make this important product candidate available to HAE patients as soon as possible."
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.
Hereditary Angioedema (HAE) is an acute inflammatory condition characterized by episodes of severe, often painful swelling affecting the extremities, the gastrointestinal tract, the genitalia, and in potentially life-threatening cases, the larynx.
Dyax is focused on advancing novel biotherapeutics for unmet medical needs, with an emphasis on oncology and inflammatory indications.