News Room

CSL Behring announced today that the U.S. Food and Drug Administration (FDA) approved Kcentra™ (Prothrombin Complex Concentrate [Human]), the first non-activated 4-factor prothrombin complex concentrate (PCC) for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (e.g., warfarin) therapy in adult patients with acute major bleeding. The pivotal clinical trial showed that Kcentra met all efficacy and safety endpoints, including the endpoints of hemostatic efficacy and International Normalized Ratio (INR) reduction compared with plasma, the most widely used agent for warfarin reversal in the United States.

CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved an expansion of the indication for Corifact®, Factor XIII Concentrate (Human), to include the peri-operative management of surgical bleeding in adult and pediatric patients with congenital factor XIII (FXIII) deficiency. In 2011, Corifact became the first and only FXIII concentrate approved in the U.S. for the routine prophylactic treatment of congenital factor XIII deficiency.

CSL Behring today announced that the United States Food and Drug Administration has approved a 40 g (400 mL) vial size for Privigen®, immune globulin intravenous [human]. The new vial size will simplify preparation and administration of the product when high volumes of it are required. Privigen is approved for the treatment of patients with primary immunodeficiency (PID), a group of rare and serious diseases of the immune system, and provides effective protection against infection by assisting the body in maintaining a normal level of immunoglobulin. Privigen is also approved in the United States for chronic immune thrombocytopenic purpura (ITP) to raise platelet counts. With the addition of the 40 g vial, Privigen will be available in four sizes in the United States, including 5 g (50 mL), 10 g (100 mL) and 20 g (200 mL). The first supply of Privigen in this new vial size will be introduced in June.

CSL Behring announced today that it has awarded $78,750 in Local Empowerment for Advocacy Development (LEAD) grants to patient advocacy organizations in New York and Ohio, and to the American Plasma Users Coalition (APLUS). LEAD grants are intended to help local patient organizations achieve their advocacy objectives by further developing an existing initiative or creating a new one.

CSL Behring and its employees helped numerous organizations throughout the United States in 2012, from local United Way chapters to patient advocacy groups, food banks and other agencies that provide vital services to people in need. With operations in King of Prussia, Pa., Kankakee, Ill. and Boca Raton, Fla., and CSL Plasma centers throughout the United States and sites in Knoxville, Tenn. and Indianapolis, Ind., the company and its employees impacted many people.

CSL Behring announced today the launch of a financial assistance program designed to cover patients’ out-of-pocket expenses for Berinert®, C1 Esterase Inhibitor (Human), a pasteurized, nanofiltered therapy indicated for the treatment of acute laryngeal, facial and abdominal attacks of hereditary angioedema (HAE). HAE is a rare and potentially fatal genetic disorder. Berinert Co-Pay BENefit is the most recent addition to the Berinert Expert Network (B.E.N.®), a full-service support program for healthcare providers and HAE patients and their caregivers. Berinert is available through specialty pharmacies and distributors in the United States.

CSL Behring has teamed up with Professional Supercross racer Carl Schlacht to launch www.IamaChamPIon.com. This new online resource is part of the I am a ChamPIon campaign, a partnership that aims to raise awareness of primary immunodeficiency disease (PI or PIDD) while encouraging those with the condition to pursue their dreams despite the challenges that PI can pose.

CSL Behring’s parent company, CSL Limited (ASX:CSL), reaffirms the company’s commitment to responsible business practice and sustainable development in its fourth Corporate Responsibility Report – Our Corporate Responsibility 2012. The report details CSL’s performance across key corporate responsibility priority areas for the period July 1, 2011 through June 30, 2012.

Each year thousands of people in the United States who suffer with rare and serious medical disorders receive lifesaving or life-enhancing therapies derived from human plasma. It takes a large number of plasma donations to create enough therapy for just one patient for an entire year. Yet, only a small number of people who are eligible to donate plasma do so.

CSL Behring announced today that it has awarded six patient advocacy organizations in the U.S. with Local Empowerment for Advocacy Development (LEAD) grants totaling nearly $70,000. LEAD grants are awarded semiannually and are intended to help local patient organizations achieve their advocacy objectives by further developing an existing initiative or developing a new one.