Dyax completes BLA for DX-88 in HAE

Massachusetts, USA-headquartered Dyax Corp has announced the completion of its Biologics License Application with the Food and Drug Administration for approval of its lead product candidate DX-88 (ecallantide) 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 agency to take action on the application.

The final portion of the 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 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 Blair, chief executive of Dyax. "We believe DX-88, a recombinant, subcutaneously -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," he added.