Blood clotting is a vital process of the body helping to close wounds. However, under certain circumstances, this process can cause severe to life-threatening diseases – so called thromboses.
An ideal anticoagulant should combine the following advantages: an oral administration, a predictable profile, a wide therapeutic window, a fixed dose without the need for routine coagulation monitoring, as well as no food or drug interactions.
Rivaroxaban specifically inhibits Factor Xa in the coagulation system, thereby controlling the generation of thrombin, an enzyme that facilitates clotting.
Rivaroxaban currently is the most extensively studied oral factor-Xa-inhibitor in clinical development. The clinical trial program will evaluate the product in the prevention and treatment of a broad range of acute and chronic blood-clotting disorders and is expected to enroll more than 65,000 patients. In September 2008,
rivaroxaban, administered as one tablet, once-daily, was approved in the EU under the brand name Xarelto™ for the prophylaxis of venous thromboembolism in adult patients after elective hip and knee replacement. Today, it is approved in this indication in more than 80 countries. In a large study program in this indication,
rivaroxaban demonstrated higher efficacy than the current standard therapy, while maintaining a similar safety profile. It does not require routine coagulation monitoring. Furthermore, because of its oral administration and fixed dosage, treatment could be facilitated for both patients and doctors. Therefore,
rivaroxaban could contribute to improve patients’ quality of life and has the potential to save lives..
In December 2009 the
“Deutscher Zukunftspreis 2009” of the German President has been awarded to an R & D team from Bayer for the development of the novel oral anticoagulant rivaroxaban.
Fact sheets: Bayer HealthCare development projects