Biopharmaceutical company Dyax Corp. (DYAX) said Tuesday that the U.S. Food and Drug Administration granted approval for Kalbitor, or ecallantide, for the treatment of acute attacks of hereditary angioedema, or HAE, in patients 16 years of age and older.
HAE is a rare, genetic disorder characterized by severe and debilitating swelling that can occur in the abdomen, face, hands, feet and airway. HAE attacks, on an average, occur over 20 times annually. These occur spontaneously with no identifiable trigger.
Kalbitor is a reversible plasma kallikrein inhibitor discovered and developed by Dyax, and is the first subcutaneous HAE treatment approved in the U.S. The approval of Kalbitor is based on the results of two placebo-controlled Phase 3 clinical studies - EDEMA3 and EDEMA4.
The company noted that potentially serious hypersensitivity reactions, including anaphylaxis, have occurred in patients treated with the drug.
As part of product approval, Dyax, together with the FDA, has established a Risk Evaluation and Mitigation Strategy program to convey the risk of anaphylaxis and the importance of understanding the difference between a hypersensitivity reaction and HAE attack symptoms.
DYAX closed Tuesday's regular trade at $3.50, down $0.23 or 6.17%, on 2.59 million shares, compared to a 3-month average volume of 466,395 shares. In the extended trade, the stock soared nearly 46% and were trading at $5.10.
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