Bayer has filed Xarelto in Japan in a bid to get the green light for the anticoagulant as a treatment for stroke.
Specifically, Xarelto (rivaroxaban) 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. The fiing 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.
The latter study was conducted with a 15mg dose of rivaroxaban once-daily, "in recognition of the Japanese guideline environment," Bayer noted. Results of the J-ROCKET AF study are planned to be presented at an upcoming major scientific meeting.__
Xarelto 20 mg once-daily has recently been submitted for marketing authorisation in stroke prevention in patients with AF in the European Union and the USA. The drug, which Bayer believes will be a blockbuster, is already on the market in over 80 countries for the prevention of venous thromboembolism in adults following elective hip or knee replacement surgery.
However the company has considerable ground to make up on fellow German firm Boehringer Ingleheim, whose bloodthinner Pradaxa (dabigatran etexilate) was approved in the USA last year for the prevention of stroke in patients with AF and has got off to a very successful start. Furthermore, Pradaxa has also been approved in Japan for that lucrative indication, a thumbs-up that came a year earlier than expected.