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Rivaroxaban submitted for approval
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Rivaroxaban submitted for approval
Leverkusen – In October 2007 Bayer HealthCare submitted a Marketing Authorization Application for the European Union to the European Medicines Agency (EMEA) for rivaroxaban (
Xarelto®) in the prevention of venous thromboembolism (VTE) after major orthopedic surgery of the lower limbs. Upon regulatory approval, Xarelto® will be marketed in Europe by Bayer Schering Pharma. The company plans to file for approval of the product by the U.S. Food and Drug Administration in 2008. Rivaroxaban is a once-daily direct Factor xa inhibitor in tablet form.
Data from the RECORD1-3 studies presented at the 49th Annual Meeting of the American Society of Hematology (ASH) revealed that rivaroxaban significantly reduces the risk of VTE in patients undergoing hip or knee replacement surgery compared with enoxaparin, the current standard-of-care therapy. Bleeding rates were low and similar in all arms of the study.
Xarelto®) in the prevention of venous thromboembolism (VTE) after major orthopedic surgery of the lower limbs. Upon regulatory approval, Xarelto® will be marketed in Europe by Bayer Schering Pharma. The company plans to file for approval of the product by the U.S. Food and Drug Administration in 2008. Rivaroxaban is a once-daily direct Factor xa inhibitor in tablet form. Data from the RECORD1-3 studies presented at the 49th Annual Meeting of the American Society of Hematology (ASH) revealed that rivaroxaban significantly reduces the risk of VTE in patients undergoing hip or knee replacement surgery compared with enoxaparin, the current standard-of-care therapy. Bleeding rates were low and similar in all arms of the study.
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