CSL Behring Receives FDA Approval of Corifact™ for Treatment of Congenital Factor XIII Deficiency
First and only factor XIII concentrate approved in U.S. to treat extremely rare and potentially life-threatening bleeding disorder
King of Prussia, PA — 18 February 2011
CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Corifact™, Factor XIII Concentrate (Human), for the routine prophylactic treatment of congenital factor XIII (FXIII) deficiency. Corifact, already available for use in 12 countries throughout the world under the trade name Fibrogammin®- P, is the first and only FXIII concentrate approved in the U.S.
Congenital FXIII deficiency, also known as fibrin-stabilizing factor deficiency, is a rare and potentially life-threatening bleeding disorder in which blood clots normally, but the clots formed are unstable, leading to recurrent bleeding. It is estimated that the condition affects one person in two million, with an incidence in the U.S. of approximately 150 people.
"FDA approval of Corifact is a very special opportunity to make a positive difference in the lives of people who need our safe, high-quality therapies, while continuing to enhance our extensive portfolio of products for people with bleeding disorders," said Lynne Powell, CSL Behring Senior Vice President, North America Commercial Operations. "Corifact is the fourth new product that CSL Behring has brought to the U.S. market in the past two years. This represents our ongoing commitment to developing products for the treatment of rare and serious diseases."
Symptoms of congenital FXIII deficiency include bleeding from the umbilical cord after birth, poor wound healing, miscarriages, subcutaneous bleeding, and excessive bleeding in joints and muscles following trauma. Patients lacking the FXIII protein are also at high-risk for intracranial hemorrhage (ICH), bleeding inside the skull that can be life-threatening. Studies have shown that between 25 and 60 percent of FXIII-deficient patients will experience an ICH at least once during their lifetime. For a doctor to accurately diagnose FXIII deficiency, specific blood testing and detailed family history are necessary.
Corifact, an intravenous (IV) infusion given approximately every 28 days, is indicated for routine prophylactic treatment of congenital FXIII deficiency. There are no controlled trials demonstrating a direct benefit on treatment of bleeding episodes with Corifact. Corifact is a fibrin-stabilizing factor concentrate that provides both A- and B-subunits to protect against FXIII deficiency. Clinical studies have shown that Corifact immediately increases FXIII levels in the blood. The concentrated formula is dosed, depending on the patient’s weight, to maintain trough FXIII levels between 5 and 20 percent of normal.
Corifact is packaged as lyophilized powder in a single-use vial with high stability and a long shelf life. The concentrate is stable for up to six months at room temperature (25°C) and 24 months when refrigerated (2-8°C). Corifact also has a low infusion volume, which could help reduce administration time.
Corifact is also available as Fibrogammin®- P in Argentina, Austria, Belgium, Brazil, France, Germany, Great Britain, Indonesia, Israel, Japan, Luxembourg, and Switzerland.
Corifact is not for individuals who experience symptoms of hypersensitivity with known anaphylactic or severe systemic reactions to human plasma-derived products or any components in the formulation. In clinical studies, the most common adverse reactions reported following treatment with Corifact include hypersensitivity (including allergy, rash, pruritus, erythema), chills/rise in temperature, arthralgia, headache, elevated thrombin-antithrombin levels, and an increase in hepatic enzymes. Physicians should monitor a patient’s trough FXIII activity level during treatment. If the expected FXIII level is not attained, or breakthrough bleeding occurs, an investigation to determine the presence of FXIII inhibitor antibodies should be performed.
Corifact undergoes virus inactivation and removal for safety assurance. Corifact is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.
For more information, including full prescribing information, visit www.corifact.com.
About CSL Behring
CSL 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 hemophilia 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.
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