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A Phase III study of HyQ, an investigational facilitated subcutaneous immune globulin (SCIG) product for use in patients with primary immunodeficiency (PIDD), has produced top-line results. In the open-label study by Baxter International Inc. and Halozyme Therapeutics Inc., 89 patients with PIDD were enrolled in 15 centers in the U.S. and Canada to evaluate the effectiveness of HyQ in the prevention of infections and to measure other secondary endpoints, including tolerability. Patients were infused with a three-week or four-week dose of 10% HyQ in a single infusion site. Results showed that the acute serious bacterial infection rate was .025 per patient per year, which is below the required efficacy threshold of 1.0. The tolerability assessment showed that the most frequently reported adverse reactions were infusion site reactions (20 percent), headache (3 percent), fatigue (1 percent) and fever (1 percent).
The data from this trial confirm the interim results presented in late 2010 and support the recent submission of a biologics license application to the U.S. Food and Drug Administration. The trial also established a foundation for the HyQ extension study that will further evaluate HyQ administration in patients through March 2012. In addition to the recent regulatory submission in the U.S., Baxter expects to file in Europe and Canada, and will present results from the Phase III study by the end of 2011.