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Rivaroxaban submitted for European approval
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Rivaroxaban submitted for European approval
Berlin. Bayer HealthCare has submitted a Marketing Authorization Application to the European medicines agency EMEA for rivaroxaban (Xarelto®) in the prevention of venous thromboembolism (VTE) after major orthopedic surgery of the lower limbs. Rivaroxaban is an oral, once-daily direct Factor Xa inhibitor. Data from the record3 study prior to the emea submission revealed that rivaroxaban significantly reduces the risk of vte in patients undergoing knee replacement surgery compared with enoxaparin, the current standard-of-care therapy.
The Marketing Authorization Application is based on data from three Phase III studies of rivaroxaban involving a total of nearly 10,000 patients, as well as extensive Phase I and Phase II study programs. To date, rivaroxaban is the most extensively studied oral direct Factor Xa inhibitor in development. More than 20,000 patients have been evaluated in the completed Phase II programs or enrolled in the Phase III programs.
The Marketing Authorization Application is based on data from three Phase III studies of rivaroxaban involving a total of nearly 10,000 patients, as well as extensive Phase I and Phase II study programs. To date, rivaroxaban is the most extensively studied oral direct Factor Xa inhibitor in development. More than 20,000 patients have been evaluated in the completed Phase II programs or enrolled in the Phase III programs.
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