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Baxter And Halozyme Announce Positive Opinion For HyQvia For Treatment Of Primary And Secondary Immunodeficiencies In The European Union
Date:3/22/2013

LONDON, March 22, 2013 /PRNewswire/ -- Baxter International Inc. (NYSE: BAX) and Halozyme Therapeutics, Inc., (NASDAQ: HALO) today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (EMA CHMP) has granted a Positive Opinion to Baxter for the use of HyQvia (solution for subcutaneous use) as replacement therapy for adult patients with primary and secondary immunodeficiencies. The product is a combination of human normal immunoglobulin (IGSC, 10%) and recombinant human hyaluronidase, which facilitates the dispersion and absorption of the IGSC. 

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"This recommendation supports our efforts to improve the overall quality of care for patients. This therapy, when approved by the European Commission, would offer patients the option to administer their therapy at home, in a single subcutaneous site every three to four weeks, resulting in potentially lower systemic adverse reactions compared to intravenous treatments," said Ludwig Hantson , Ph.D., president of Baxter's BioScience business. "We look forward to introducing HyQvia as a new patient-friendly therapeutic option for immunodeficient patients."

The application was based on results from a phase III, prospective, open-label, non-controlled design clinical trial, which evaluated the safety and effectiveness of HyQvia in the prevention of acute serious bacterial infections, and the pharmacokinetic parameters compared to immunoglobulin administered intravenously. The objective of the study was to infuse a 3-or 4-week dose of the therapy in a single subc
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SOURCE Halozyme Therapeutics, Inc.
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