FDA sanctioned Dyax’ reversible plasma kallikrein inhibitor, Kalbitor®, for the treatment of acute attacks of hereditary angioedema (HAE) in patients 16 years of age and older. The company says that the drug is the first subcutaneous HAE treatment approved in the U.S.
Due to a 3.9% incidence of anaphylaxis observed in Kalbitor clinical trials, Dyax has worked with FDA to establish a Risk Evaluation and Mitigation Strategy program. This will communicate the risk and the importance of distinguishing between a hypersensitivity reaction and HAE attack symptoms.
The product is separately in development by Dyax’ licensee, Cubist Pharmaceuticals, for use in the prevention of blood loss during on-pump (cardiopulmonary bypass) cardiothoracic surgery. Cubist’s license covers North America and Europe, and Phase II trials are ongoing in both regions.