The marketing authorization application is based on data from three Phase III studies of rivaroxaban in the prevention of venous thromboembolism after major orthopedic surgery of the lower limbs. The studies involved nearly 10,000 patients in total, and an extensive Phase I and Phase II program.
Rivaroxaban is an investigational, oral, once-daily direct Factor Xa inhibitor and is being jointly developed by Bayer HealthCare and Johnson & Johnson Pharmaceutical R&D.
Kemal Malik, head of global development and member of the Bayer HealthCare executive committee, said: “The submission of the data for venous thromboembolism (VTE) prevention to the EMEA is an important milestone in the development of this new treatment for the prevention of life-threatening blood clots. As an effective and convenient, once-daily oral treatment with a reassuring safety profile, we feel confident that rivaroxaban has the potential to set a new standard of care in the preventative treatment of thrombosis in patients undergoing major orthopedic surgery.”