Dyax, a clinical stage biotechnology company, has announced that the FDA has accepted for filing the company's biologics license application for DX-88 for the treatment of acute attacks of hereditary angioedema and has designated the application for priority review.
Based on this designation, the FDA Prescription Drug User Fee Act target action date is March 23, 2009, or six months from the biologics license application (BLA) submission date of September 23, 2008. Priority review designation is intended for those products that address unmet medical needs.
The BLA submission is based primarily on data from two placebo-controlled Phase III clinical studies, EDEMA3 and EDEMA4, which, taken together, represent the largest placebo-controlled evaluation of any therapy used in the treatment of hereditary angioedema, the company said. In these studies, DX-88 demonstrated statistically significant improvements over placebo in both the primary and secondary endpoints.
Henry Blair, chairman, president and CEO of Dyax, said: "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."