Bayer's Rivaroxaban Submitted for Approval in Japan
Bayer has submitted its rivaroxaban to the Japanese Ministry of Health, Labor and Welfare for marketing approval in the prevention of stroke in patients with atrial fibrillation.
Bayer's oral anticoagulant, rivaroxaban (Xarelto), has been submitted for marketing approval in the prevention of stroke in patients with atrial fibrillation to the Japanese Ministry of Health, Labor and Welfare (MHLW).
The submission to the MHLW is based on the results of the global ROCKET AF study and the Phase III J-ROCKET AF study, which was run entirely in Japan. Both studies investigated rivaroxaban versus dose-adjusted warfarin in patients with non-valvular atrial fibrillation at risk of stroke. The J-ROCKET AF trial was conducted with a 15 mg dose of rivaroxaban once daily, in recognition of the Japanese guideline environment. Results of the J-ROCKET AF study are planned to be presented at an upcoming major scientific meeting.
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