Bayer Healthcare has submitted rivaroxaban (Xarelto), an oral anticoagulant, for marketing approval to the Japanese Ministry of Health, Labor and Welfare. The drug is indicated for the prevention of stroke in atrial fibrillation patients.
The marketing approval submission is based off of the positive results of the ROCKET AF study and Phase III J-ROCKET AF study, which both evaluated the use of rivaroxaban versus dose-adjusted warfarin in non-valvular AF patients at risk for stroke.
The 20 mg dose of the drug has already been submitted for marketing approval in the EU and the U.S.
Rivaroxaban, developed jointly by Bayer Healthcare and Johnson & Johnson, has a current market indication for venous thromboembolism in adult patients following elective knee or hip surgery.