FDA expands approval for Kalbitor in Hereditory Angioedema - Dyax
The FDA has approved an expansion of the indication for Kalbitor (ecallantide), from Dyax, for the treatment of Acute Hereditary Angioedema (HAE) attacks, to include patients 12 years of age and older. With this approval, Kalbitor is the first and only subcutaneous therapy available to treat acute attacks of HAE in patients 12 years of age and older.
The FDA approval of this label expansion for Kalbitor is supported by the results from two previously completed Phase III 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 adult population.
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