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FDA Approves Expanded Use of Kalbitor for the Treatment of HAE to Patients 12 Years of Age and Older
Posted 7 Apr 2014 by Drugs.com
BURLINGTON, Mass.--(BUSINESS WIRE)-- Dyax Corp. (NASDAQ:DYAX) today announced that the U.S. Food and Drug Administration (FDA) has approved an expansion of the indication for 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. 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. Kalbitor is also the only therapy that is not purified from human plasma that has been approved to treat this patient group. The FDA approval of this label expansion for Kalbitor is supported by the results from two previously completed Phase 3 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 o ... Read more