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Jazz Pharmaceuticals PLC Announces Presentation Of Largest Safety Trial To Date Of Patients Treated With Erwinaze


Monday, 10 Dec 2012 06:52pm EST 

Jazz Pharmaceuticals PLC announced that data from the largest safety trial to date of patients treated with Erwinaze (asparaginase Erwinia chrysanthemi) have been presented at the American Society of Hematology Annual Meeting and Exposition taking place in Atlanta, Georgia. The poster presentation is based on results of a compassionate use protocol in patients who received Erwinaze as part of a multi-agent chemotherapeutic regimen for acute lymphoblastic leukemia who developed a hypersensitivity to E.coli-derived asparaginase. The poster summarizes the safety results in 940 patients at participating U.S. oncology treatment centers between February 2006 and November 2011, when Erwinaze was available under a compassionate use protocol prior to its approval by the U.S. Food and Drug Administration in November 2011. The trial includes additional follow up data that further describe the incidence of adverse events associated with Erwinaze treatment, which are consistent with the known safety profile of Erwinaze. Erwinaze is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity to E.coli-derived asparaginase. Erwinaze was originally discovered by the UK Health Protection Agency. Erwinaze was approved by the U.S. Food and Drug Administration in November 2011. 

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