Jazz Pharmaceuticals Receives FDA Approval For Intravenous Administration Of Erwinaze® (asparaginase Erwinia chrysanthemi)

-- Expanded U.S. Labeling Offers an Alternative Method to Administer Erwinaze to Patients with ALL

DUBLIN, Dec. 20, 2014 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) approved the intravenous administration of Erwinaze® (asparaginase Erwinia chrysanthemi). 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 asparaginase¹.

"Administration of Erwinaze through an intravenous infusion provides physicians another option for patients, including those who cannot tolerate intramuscular injections," said Jeffrey Tobias, M.D., executive vice president, research and development and chief medical officer of Jazz Pharmaceuticals plc. "Gaining FDA approval of this expanded label for Erwinaze reflects our continued commitment to improving patients' lives."

Prior to this approval, the only approved route of administration for Erwinaze was through intramuscular injection. With the expanded label, the formulation of Erwinaze currently on the market may now be administered to patients by either intravenous infusion or intramuscular injection. The updated product label provides data and information to help physicians understand the different administration options and determine which route of administration is most appropriate for their patients.

The FDA approval was based on a pharmacokinetic study of intravenous asparaginase Erwinia chrysanthemi following hypersensitivity to E coli-derived asparaginase. The intravenous administration trial was conducted at 10 centers in the U.S. and recruited a total of 30 patients, of which 24 patients were evaluable for the primary endpoint, which was the proportion of patients having an asparaginase activity level of greater than 0.1 IU/mL 48 hours after dosing^{1, 2}.

About Erwinaze
Erwinaze® (asparaginase Erwinia chrysanthemi) is currently approved in the U.S. for administration via intramuscular injection or via intravenous infusion in conjunction with chemotherapy. It 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 asparaginase¹. Erwinaze is derived from the bacterium Erwinia chrysanthemi and is therefore immunologically distinct from E. coli-derived asparaginase and suitable for patients with hypersensitivity to E. coli-derived treatments³. Outside of the U.S., Erwinaze is sold under the name Erwinase®. Please consult local labeling for product information specific to your country.