FDA Approves Expanded Use Of Kalbitor For Angioedema Patients 12 & Older

Dyax has announced that the U.S. Food and Drug Administration (FDA) approved an extension of the indication for the drug Kalbitor (ecallantide). Kalbitor is a peptide inhibitor of plasma kallikrein used for the treatment of a rare swelling disease named angioedema. This therapy is the only one not purified from human plasma that has been approved to treat this patient group.

 Angioedema usually affects patients as they hit puberty and causes swelling of the face and airways. The disease is rare, and only affects an estimated 6,500 people worldwide. Kalbitor is one of only four drugs available in the U.S. for treating hereditary angioedema, or HAE. In 2009, Kalbitor was approved by the FDA for treating patients age 16 or older. This year's new approval of the drug allows patients as young as 12 to be treated with Kalbitor. The drug is administered via injection instead of intravenously for young patients. Dyax company spokeswoman Jennifer Robinson explained that Kalbitor is the only HAE drug on the market that can be administered via injection. “Dyax is focused on providing the HAE community with multiple options to treat the disease,” said Robinson.

Gustav Christensen, the President and CEO of Dyax, also released a statement regarding the drug's approval for younger patients. “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 Dyax and the children and families who are affected by this disease,” said Christensen. “We remain committed to providing access to novel therapeutics and first-class patient services to the HAE community.”

Dyax is also developing another drug which will be able to prevent HAE attacks. The drug will undergo Phase 1b trials in the upcoming months. The company already offers an in-home, 24 hour service named Kalbitor Home Infusion Services. The service allows patients to get care from a trained nurse in their home to help treat sudden HAE attacks.