Dyax Gets FDA Approval To Expand Use Of Kalbitor To Patients 12 Years And Older

(RTTNews) - Dyax Corp. (DYAX) said Thursday that the U.S. Food and Drug Administration has approved an expansion of the indication for Kalbitor, a peptide inhibitor of plasma kallikrein used in the treatment of acute hereditary angioedema attacks, to include patients 12 years of age and older.

With the approval, Kalbitor is the first and only subcutaneous therapy available to treat acute attacks of hereditary angioedema in patients 12 years of age and older. Kalbitor is also the only therapy that is not purified from human plasma that has been approved to treat this patient group.

The FDA approval of the label expansion for Kalbitor is supported by the results from two previously completed Phase 3 placebo-controlled clinical studies, known as EDEMA3 and EDEMA4 as well as the results of study DX-88/19, which was ongoing at the time of the original approval of Kalbitor. The efficacy and safety profile observed in pediatric patients 12 years of age and older is similar to the population.