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Phase II Study Indicates That Fibrinogen Concentrate Given As A First-Line Therapy Safely Reduces Need For Transfusion After Aortic Surgery

About fibrinogen concentrate [human]

CSL Behring manufactures a purified fibrinogen concentrate marketed under the name Haemocomplettan ® P which is licensed for an acquired bleeding indication in the following countries: Austria, Brazil, Bulgaria, Czech Republic, Germany, Hungary, Iran, Israel, Kuwait, Netherlands, Portugal, Romania, Switzerland, Taiwan, and Turkey.

CSL Behring is conducting a Phase III study to further investigate the utility of fibrinogen concentrate in complex cardiovascular surgery. Its utility is also being investigated in a range of other clinical indications, including liver disease, postpartum haemorrhage and trauma, in which a critical reduction in the level of coagulation factors can lead to additional non-surgical bleeding complications.

In the United States, fibrinogen concentrate is indicated for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenaemia and hypofibrinogenaemia. Afibrinogenaemia, or congenital fibrinogen deficiency, is a rare and life-threatening disorder that results from a deficiency in fibrinogen that prevents blood from clotting normally. This disease is inherited and can occur in men and women. [7] Approximately one in one million people in Western countries have this disorder. [8]

About CSL BehringCSL Behring is a leader in the plasma protein therapeutics industry. Committed to saving lives and improving the quality of life for people with rare and serious diseases, the company manufactures and markets a range of plasma-derived and recombinant therapies worldwide. CSL Behring therapies are indicated for the treatment of coagulation disorders including haemophilia and von Willebrand disease, primary immune deficiencies, hereditary angioedema and inherited respiratory disease. The company's products are also used in cardiac surgery, organ transplantation, burn treatment and to prevent hemolytic diseases in newborns. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. CSL Behring is a subsidiary of CSL Limited (ASX: CSL), a biopharmaceutical company headquartered in Melbourne, Australia. For more information, visit www.cslbehring.com.

Media Contacts: Sheila A. Burke1020 First AvenuePO Box 61501 King of Prussia, PA 19406610-878-4209 sheila.burke@cslbehring.com

Etanjalie AyalaWeber Shandwick212-445-8225 eayala@webershandwick.com


[1] Rahe-Meyer N, et al. Bleeding management with fibrinogen concentrate targeting a high-normal plasma fibrinogen level: A pilot study. Br J Anaesth. 2009;102:785-92

[2] Rahe-Meyer N, et al. Thromboelastometry-guided administration of fibrinogen concentrate for the treatment of excessive intraoperative bleeding in thoracoabdominal aortic aneurysm surgery. J Thorac Cardiovasc Surg. 2009;138:694-702

[3] Reinhofer M, et al. The value of rotation thromboelastometry to monitor disturbed perioperative haemostasis and bleeding risk in patients with cardiopulmonary bypass. Blood Coagul Fibrinolysis. 2008;19:212-9

[4] Medline Plus. Fibrinogen. http://www.nlm.nih.gov/medlineplus/ency/article/003650.htm

[5] Lowe GDO, et al. Ann Clin Biochem. 2004;41:430-40

[6] Blome M, et al. Relationship between factor XIII activity, fibrinogen, haemostasis screening tests and post-operative bleeding in cardiopulmonary bypass surgery. Thromb Haemost. 2005;93:1101-7.

[7] Medline Plus. Afibrinogenaemia. http://www.nlm.nih.gov/medlineplus/ency/article/001313.htm

[8] Rare Bleeding Disorders Database. http://www.rbdd.org/index.php?option=com_content&view=article&id=72

 

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