FDA Accepts Filing and Grants Priority Review for Dyax' DX-88 for Hereditary Angioedema
"The FDA's decision to grant Priority Review underscores the urgent need to address the treatment of acute attacks of hereditary angioedema," commented Henry E. Blair, Chairman, President and Chief Executive Officer of Dyax. "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."
The BLA submission is based primarily on data from two placebo-controlled Phase 3 clinical studies, EDEMA3 and EDEMA4, which, taken 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.
Most read news
Topics
Organizations
Other news from the department research and development
Get the life science industry in your inbox
From now on, don't miss a thing: Our newsletter for biotechnology, pharma and life sciences brings you up to date every Tuesday and Thursday. The latest industry news, product highlights and innovations - compact and easy to understand in your inbox. Researched by us so you don't have to.