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FDA approves Dyax's Kalbitor for HAE

December 2, 2009 1:17 AM UTC

FDA approved a BLA from Dyax Corp. (NASDAQ:DYAX) for Kalbitor ecallantide ( DX-88) to treat acute attacks of hereditary angioedema (HAE) in patients 16 years old and up. Dyax said the BLA was approved with a risk evaluation and mitigation strategy (REMS) to communicate the risk of anaphylaxis and the importance of distinguishing between a hypersensitivity reaction and HAE attack symptoms. The agency had requested a REMS in a March complete response letter. ...