September 25, 2008
Dyax Completes BLA for Hereditary Angioedema Drug
Dyax, a clinical stage biotechnology company, has completed its biologics license application with the FDA for approval of the company's lead product candidate DX-88 for the treatment of hereditary angioedema.
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.
The final portion of the biologics license application (BLA), the clinical section, was based primarily on data from two Phase III clinical studies, Edema3 and Edema4, which together represent the largest placebo-controlled evaluation of any therapy used in the treatment of hereditary angioedema (HAE), 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: "The submission of the DX-88 BLA is a major milestone for 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."