|Dyax Receives FDA Approval to Expand Use of KALBITOR®; IntegraGen Announces Agreement with Pfizer to Evaluate Proprietary Hepatocellular Carcinoma Molecular Signature|
|By Staff and Wire Reports|
|Thursday, 03 April 2014 20:36|
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 original approval of KALBITOR. The efficacy and safety profile observed in pediatric patients 12 years of age and older is similar to the adult population.
“KALBITOR has an established track record in the HAE marketplace and this FDA approval for the expanded use in pediatric patients is an important achievement for both Dyax and the children and families who are affected by this disease,” said Gustav Christensen, President and Chief Executive Officer of Dyax. “We remain committed to providing access to novel therapeutics and first-class patient services to the HAE community.”
About KALBITOR (ecallantide) KALBITOR is a plasma kallikrein inhibitor indicated for the treatment of acute attacks of HAE in patients 12 years of age and older. KALBITOR, which was discovered and developed by Dyax, was the first subcutaneous treatment available in the U.S. for treating acute HAE attacks. Anaphylaxis has been reported after administration of KALBITOR. Because of the risk of anaphylaxis, KALBITOR should only be administered by a healthcare professional with appropriate medical support to manage anaphylaxis and HAE.
IntegraGen, a leading player in the development and marketing of molecular diagnostic testing in oncology and autism, announced today that it has entered into an agreement with Pfizer Inc. (NYSE:PFE) that provides Pfizer access to evaluate the company’s proprietary molecular signature for hepatocellular carcinoma. The 56-gene molecular signature covered by the agreement is intended to predict the clinical prognosis of patients with hepatocellular carcinoma and subcategorize patients into six separate classifications based on the molecular characteristics of their liver tumors.
“We are pleased to have our molecular signature evaluated by one of the world’s leading pharmaceutical companies,” said Dr. Bernard Courtieu, IntegraGen’s Chief Executive Officer. “The use of our molecular signature may help to identify specific patient populations who would benefit from Pfizer’s experimental compounds, if approved by regulatory authorities. We are also extremely appreciative of the research conducted by Professor Jessica Zucman-Rossi which led to the development of this molecular signature with the continued support of the French League Against Cancer Program ‘Cartes d’Identité des Tumeurs®’ (CIT).”
Terms of the agreement were not disclosed.
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