Bayer files for approval of Xarelto for stroke prevention in Japan
German drug major Bayer (BYA: DE) says it has filed for approval of its blood thinner Xarelto (rivaroxaban) as a prevention of stroke in patients with atrial fibrillation with 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 15mg 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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