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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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Bleeding Disorders

28 July 2015 U.S. FDA Accepts for Review CSL Behring’s Biologics License Application for Its Novel rVIII-SingleChain Therapy for Patients with Hemophilia A

CSL Behring announced today that the U.S. Food and Drug Administration has accepted for review the company’s Biologics License Application (BLA) for its novel investigational recombinant factor VIII single-chain (rVIII-SingleChain) for the treatment of hemophilia A. In the pivotal clinical trial, rVIII-SingleChain met all primary endpoints.

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28 July 2015 Swissmedic Accepts for Review CSL Behring’s MAA for rIX-FP for Patients with Hemophilia B

CSL Behring announced today that Swissmedic has accepted for review a Marketing Authorization Application (MAA) for the company’s investigational long-acting fusion protein linking recombinant coagulation factor IX with recombinant albumin (rIX-FP) for the prophylaxis and treatment of bleeding episodes in people with Hemophilia B. Upon Swissmedic approval, rIX-FP will provide hemophilia B patients with a long-acting treatment option with dosing intervals up to 14 days.

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24 June 2015 CSL Behring Presents rIX-FP for Hemophilia B Phase III Data Evaluating Efficacy, Safety and Improved Dosing at ISTH 2015

CSL Behring today presented data from Phase III studies evaluating the efficacy and long-term safety of its investigational long-acting fusion protein linking recombinant coagulation factor IX with recombinant albumin (rIX-FP). The data, shared in three separate oral presentations at the 2015 International Society on Thrombosis and Haemostasis (ISTH) Congress in Toronto, support the use of rIX-FP for routine prophylaxis, dosed once up to every 14 days, and for on-demand treatment of bleeding episodes in previously-treated adults and children with hemophilia B. The findings also include efficacy and safety results supporting the use of rIX-FP in patients undergoing surgical procedures.

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24 June 2015 CSL Behring Announces Pivotal Data of Novel rVIII-SingleChain Therapy in Adolescents and Adults with Hemophilia A

CSL Behring today presented data from a Phase I/III study on the efficacy and safety of its novel investigational recombinant factor VIII single chain (rVIII-SingleChain) in adolescents and adults with hemophilia A during a late breaking abstract session at the 2015 International Society on Thrombosis and Haemostasis (ISTH) Congress. Overall, patients using rVIII-SingleChain to prevent bleeding (prophylaxis) were well controlled with two to three infusions per week and developed no inhibitors.

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16 June 2015 CSL Behring to Present Pivotal Data for rVIII-SingleChain and rIX-FP at 2015 ISTH Congress

CSL Behring announced today it will present more than 20 abstracts, including five oral presentations, from across its hematology portfolio of investigational and branded products at the 2015 International Society on Thrombosis and Haemostasis (ISTH) Congress, being held in Toronto June 20-25. The presentations will include pivotal trial data for two of its late-stage recombinant products – its novel recombinant factor VIII SingleChain (rVIII-SingleChain) compound for hemophilia A and its long-acting recombinant factor IX albumin fusion protein (rIX-FP) for hemophilia B.

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