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This section features CSL Behring news releases that are more than 18 months old. Click the tabs to select releases in your area of interest. Click Resources to find additional background material on CSL Behring.

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Immunology

04 March 2010 CSL Behring Receives FDA Approval of Hizentra™, First 20 Percent Subcutaneous Immunoglobulin Therapy

CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Hizentra™, Immune Globulin Subcutaneous (Human), 20% Liquid, for treating patients diagnosed with primary immunodeficiency (PI). A once weekly immunoglobulin (Ig) replacement therapy, Hizentra provides effective protection against infection by maintaining a steady and normal level of immunoglobulin in the body. Primary immunodeficiencies constitute a group of disorders, usually genetic, that cause a malfunction in all or part of the immune system, thereby rendering the patient unable to fight off infections caused by everyday germs.

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01 March 2010 IgPro20, the First 20 Percent Subcutaneous Immunoglobulin, Demonstrates Efficacy Against Infections While Maintaining Tolerability in Patients with Primary Immunodeficiency

Data presented today suggest that 20 percent liquid formulation, Immune Globulin Subcutaneous (Human) (SCIg), or IgPro20 effectively protects patients with primary immunodeficiencies (PI) against infection. The 20 percent formulation, the highest Ig concentration currently available, was also shown to sustain serum IgG levels without causing unexpected rates of adverse events. The data were presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in New Orleans, LA, US.

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01 March 2010 European Data Suggest Switching Patients to IgPro20 May Significantly Reduce Drug Administration Volume

Data from a European multicenter (non-IND study) showing that patients with PI who switched to IgPro20 from previously available SCIg formulations achieved comparable IgG trough levels without dosage adjustment, resulting in significantly less administration volume. The data were presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in New Orleans, LA, US.

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01 March 2010 New Data Show IgPro20 Delivers Highest Available Subcutaneous Ig Concentration with Tolerability Comparable to Current Treatments

Data presented today show that IgPro20, the first 20 percent liquid formulation, delivers a higher concentration of treatment, with no trade-off in terms of local tolerability relative to currently marketed subcutaneous immunoglobulin (SCIg) products. The data were presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in New Orleans, LA, US.

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01 May 2009 CSL Behring Submits BLA Requesting Approval of Subcutaneous Human Immunoglobulin for Use as Replacement Therapy in Patients with Primary Immunodeficiencies

CSL Behring announced today it has submitted a biologics license application (BLA) to the United States Food and Drug Administration (USFDA) requesting approval to market its 20 percent liquid formulation, Immune Globulin Subcutaneous (Human) (IgSc), in the United States for weekly replacement therapy in patients with primary immunodeficiencies (PI).

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