Baxter International Inc Receives Marketing Authorization For Hyqvia In European Union


Tuesday, 21 May 2013 09:00am EDT 

Baxter International Inc and Halozyme Therapeutics, Inc announced that the European Commission has granted Baxter marketing authorization in all European Union (EU) Member States for the use of HyQvia (solution for subcutaneous use) as replacement therapy for adult patients with primary and secondary immunodeficiencies. Baxter will introduce HyQvia in select countries during 2013 and plans to expand the launch to other EU countries in 2014. 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 multi-center 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 treatment in a single subcutaneous site. The rate of validated acute serious bacterial infections in the study was 0.025 per patient per year, which is below the required efficacy threshold of 1.0 (serious bacterial infections per patient per year). In the tolerability assessment of HyQvia, the most 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). 

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