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.

Xarelto - which was recently awarded the prestigious Prix Galien (The Pharma Letter April 6) - is already approved in around 100 countries, and marketed in 80, for the prevention of venous thromboembolism (VTE) in adult patients following elective hip or knee replacement surgery, but has thus far generated only modest sales. The drug’s blockbuster potential is seen as coming from additional uses such as stroke prevention in AF patients, an indication which is still under review in both the European Union and the USA at a 20mg once-daily dosage.