FDA Expands Indication for Dyax’s Kalbitor
Burlington, Mass., drugmaker Dyax said Thursday that the FDA agreed to an expanded indication for Kalbitor to treat acute attacks of hereditary angioedema in patients ages 12 and older. The drug previously was approved in patients no younger than 16.
The indication is supported by two Phase III studies showing safety and efficacy of Kalbitor (ecallantide) in pediatric patients 12 and older was similar to that of adults.
Kalbitor, a peptide inhibitor of plasma kallikrein, is the first and only subcutaneous therapy for acute HAE attacks for this age group, according to the company. It works by blocking the production of bradykinin, a protein that normally causes blood vessels to dilate, causing swelling.
Dyax spokeswoman Jennifer Robinson told Drug Daily Bulletin that the company has partnership agreements with CVie in China and Novellus in Latin America and is exploring others in Japan. Dyax expects to begin a Phase I trial of DX-2930, a human monoclonal antibody that inhibits plasma kallikrein, in the middle of this year. — Lena Freund
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