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news.The US Food and Drug Administration (FDA) has approved an expansion of the indication for Dyax's Kalbitor (ecallantide), a peptide inhibitor of plasma kallikrein used in the treatment of acute hereditary angioedema (HAE) attacks, to include patients 12 years of age and older.
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With the 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 drug is also the only therapy that is not purified from human plasma that has been approved to treat this patient group.
The approval of this label expansion for Kalbitor is supported by the results from two previously completed Phase III placebo-controlled clinical trials, called 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 company said that the efficacy and safety profile observed in pediatric patients 12 years of age and older is similar to the adult population.
Dyax president and chief executive officer Gustav Christensen said Kalbitor has an established track record in the HAE marketplace and this FDA approval for the expanded use in pediatric patients is an important achievement for both the company and the children and families who are affected by this disease.
"We remain committed to providing access to novel therapeutics and first-class patient services to the HAE community," Christensen said.