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.
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."