Bayer has published data from a study which shows that the safety of its once-daily oral anticoagulant Xarelto is comparable to warfarin in Japanese patients with atrial fibrillation.
The German drugmaker presented results from the Phase III J-ROCKET AF study at the Congress of the International Society on Thrombosis and Haemostasis in Kyoto. They demonstrate non-inferiority of Xarelto (rivaroxaban) versus warfarin for the principal safety outcome, namely the composite of major and non-major clinically relevant bleeding.
In addition, Bayer noted that J-ROCKET AF showed a 51% reduction of stroke and non-CNS systemic embolism in the Xarelto group compared with patients receiving warfarin. However, this was not statistically significant, as the trial was not powered for efficacy.
Masatsugu Hori, head of the steering committee for the study and president of the Osaka Medical Center for Cancer and Cardiovascular Diseases, said the data are "supportive of the results of the global ROCKET AF trial". He added that "I expect rivaroxaban to become an alternative to warfarin for Japanese patients suffering from non-valvular AF".
Xarelto was submitted for marketing approval in the prevention of stroke in patients with AF to the Japanese Ministry of Health, Labor and Welfare in April. The US Food and Drug Administration gave the green light to the drug, which is partnered with Johnson & Johnson, for the prevention of deep vein thrombosis which may lead to a pulmonary embolism in people undergoing knee or hip replacement surgery earlier this month; it has been available for the above indication in Europe since 2008.
Bayer has forecast Xarelto sales of over 2 billion euros, most of which would be derived from the AF indication.