Dyax announced that the FDA has expanded the indication for Kalbitor (ecallantide) to include patients >12 years old. This approval marks Kalbitor as the first subcutaneous (SC) and non-human plasma purified therapy available to treat acute attacks of hereditary angioedema (HAE) in this age group. Kalbitor was initially approved for treatment in patients >16 years old.
Kalbitor, a plasma kallikrein inhibitor, binds to plasma kallikrein and blocks its binding site, inhibiting the conversion of HMW kininogen to bradykinin. By directly inhibiting plasma kallikrein, Kalbitor reduces the conversion of HMW kininogen to bradykinin and thereby treats symptoms of the disease during acute episodic attacks of HAE.
The FDA’s approval of this label expansion was based on results from two Phase 3 placebo-controlled studies EDEMA3 and EDEMA4, as well as the results of study DX-88/19, which was ongoing at the time of initial approval. The efficacy and safety profiles observed in pediatric patients >12 years old was similar to the adult population.
For more information call (888) 452-5248 or visit Kalbitor.com.