Dyax Corp. (Nasdaq: DYAX) focuses on the advancement of novel biotherapeutics, such as those for the treatment of hereditary angiodema (HAE), a rare and potentially life-threatening condition that occurs in about one in every 10,000 to 50,000 people. The condition is associated with swelling in various parts of the body (including hands, feet, face and airway), abdominal pain, and nausea and vomiting.
Dyax today announced the completion of its Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for approval of Dyax’s flagship product, DX-88 (ecallantide), for the treatment of HAE.
“The submission of the DX-88 BLA is a major milestone for Dyax,” Henry E. Blair, chairman, president and CEO of Dyax stated in the press release. “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.”
If granted FDA Priority Review, as requested by the company, Dyax will set a six-month target date from receipt of the completed submission for the FDA to take action on the application. Priority review is intended for those products that address unmet medical needs. DX-88 has already been granted Fast Track status by the FDA, as well as Orphan Drug designation.
The company’s BLA was based primarily on the data from two phase 3 clinical studies, regarding EDEMA3 and EDEMA4, which together represent the largest placebo-controlled evaluation of any therapy used in the treatment of HAE. According to the company, DX-88 demonstrated statistically significant improvements over placebo in both the primary and secondary endpoints in both of these studies.
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