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CSL Behring Receives FDA Approval of RiaSTAP(TM), First and Only Approved Treatment of Acute Bleeding Episodes in Patients with Congenital Fibrinogen Deficiency
Date:1/16/2009

KING OF PRUSSIA, Pa., Jan. 16 /PRNewswire/ -- CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for RiaSTAP(TM), the first and only treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. Congenital fibrinogen deficiency is a rare, potentially life-threatening bleeding disorder that affects an estimated one person per million, with an estimated prevalence in the U.S. of approximately 300 patients. RiaSTAP is not indicated to treat dysfibrinogenemia.

RiaSTAP was granted orphan status in March 2008 and priority review in August 2008. Approval was based on a pivotal phase II prospective, open-label pharmacokinetic (PK) and safety study using maximum clot firmness (MCF) as a surrogate endpoint for hemostatic efficacy. MCF is a laboratory measure of the structural integrity of the clot, reflecting the underlying effectiveness of the fibrinogen present to form a fibrin clot.

"The FDA approval of RiaSTAP underscores CSL Behring's ongoing commitment to addressing the unmet needs of patients with rare and serious bleeding disorders," said Robert Lefebvre, General Manager and Vice President of CSL Behring's U.S. Commercial Operations. "As a leader in developing safe, effective and high-quality biologic therapies, CSL Behring is pleased to introduce a product for congenital fibrinogen deficiency that provides a new therapeutic option to support hemostasis and clot stability."

Fibrinogen, also called Factor I (one), is a protein needed to form a blood clot. Fibrinogen levels in plasma determine the potential clotting ability and activity in the body. Diminished concentrations of fibrinogen limit the body's ability to form a clot. Certain fibrinogen levels usually indicate normal blood clotting ability, though in rare instances a person can have a normal quantity of fibrinogen
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