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Baxter International Inc And Halozyme Therapeutics Inc Announces Positive Opinion For HyQvia For Treatment Of Primary And Secondary Immunodeficiencies In European Union


Friday, 22 Mar 2013 08:30am EDT 

Baxter International Inc and Halozyme Therapeutics Inc announced that 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. 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 prevention of acute serious bacterial infections, and the pharmacokinetic parameters compared to immunoglobulin administered intravenously. The objective of study was to infuse a 3-or 4-week dose of the therapy in a single subcutaneous site. The acute serious bacterial infection rate in the study was 0.025 per patient per year, which is below required efficacy threshold of 1.0 (serious bacterial infections per patient per year). In tolerability assessment of HyQvia, the frequently reported adverse reactions were infusion site reactions (20% of infusions), headache (3% of infusions), fatigue (1% of infusions) and pyrexia (fever) (1% of infusions). Upon receiving marketing authorization from the European Commission, Baxter plans to launch HyQvia in selected countries in European Union later this year. 

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