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News Release Archive

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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30 May 2012 CSL Behring Submits Marketing Authorization Variation Application to European Medicines Agency (EMA) for Privigen® in Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

CSL Behring announced today that it has submitted a Variation Application to the European Medicines Agency (EMA) for the use of Privigen® (immune globulin intravenous [human], 10 percent liquid for intravenous administration) in Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP). CIDP is a rare neurological disorder of the peripheral nerves characterized by symmetrical weakness in the arms and legs that progressively worsens for longer than two months. CSL Behring is a subsidiary of CSL Limited (ASX:CSL), a biopharmaceutical company headquartered in Melbourne, Australia.

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29 May 2012 CSL Behring Announces FDA Filing of Biologics License Application for 4-Factor PCC for Urgent Reversal of Vitamin K Antagonist Anticoagulant Therapy

CSL Behring today announced that the U.S. Food and Drug Administration (FDA) has accepted for standard review its Biologics License Application (BLA) for a human 4-factor prothrombin complex concentrate (PCC) for the urgent reversal of vitamin K-antagonist therapy (i.e., warfarin) in patients with acute major bleeding. If approved by the FDA, the CSL Behring 4-factor PCC would be the first agent of its kind available in the United States.

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03 May 2012 CSL Behring Initiates Study of Subcutaneous Administration of C1-esterase inhibitor in Patients with Hereditary Angioedema

CSL Behring announced today that it has initiated an international phase I/II study of a volume-reduced, subcutaneous formulation of C1-esterase inhibitor (C1-INH) concentrate in patients with hereditary angioedema (HAE). Part of the COMPACT (Clinical Studies for Optimal Management in Preventing Angioedema with Low-Volume Subcutaneous C1-inhibitor Replacement Therapy) program, the study will evaluate the pharmacokinetics, pharmacodynamics and safety of various doses of this presentation of C1-INH.

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18 April 2012 Diagnosis Improves Quality of Life for Those With Bleeding Disorder

As a little girl, Kristin Prior came to view what others may have seen as out of the ordinary as normal: The slightest tap or bump would result in a severe bruise and nosebleeds came often and without warning. As a teenager and into adulthood Kristin’s menstrual periods would be long, heavy and burdensome. Often these symptoms kept her from taking part in activities with friends and family or left her worried about what she might encounter when she did.

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18 April 2012 HealthyWomen Asks: Do You Know the Signs and Symptoms of Von Willebrand Disease (VWD)?

Although von Willebrand disease (VWD) is the most common hereditary bleeding disorder in the United States, affecting up to 1 percent of the population, it is often misdiagnosed or under-diagnosed in women. HealthyWomen, the nation's leading nonprofit health information source for women, has developed new educational materials they hope will shine a light on a disorder that, when undiagnosed and untreated, can severely impact the quality of life for women.

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