Bayer and Johnson & Johnson are looking to get a third approval in the USA for the oral anticoagulant Xarelto.
The German group noted that its US partner has submitted a supplemental New Drug Application to the Food and Drug Administration for Xarelto(rivaroxaban) to be used in combination with standard antiplatelet therapy to reduce the risk of thrombotic cardiovascular events in patients with acute coronary syndrome. The filing is based on data from the Phase III ATLAS ACS 2-TIMI 51 trial, which showed that the combination of Xarelto 2.5 mg twice a day with standard antiplatelet therapy significantly reduced the composite primary efficacy endpoint of cardiovascular death, myocardial infarction or stroke in patients after a recent ACS compared to those receiving antiplatelet therapy alone.
In addition, the combo significantly reduced both the rate of cardiovascular death and the incidence of all-cause mortality by more than 30% over standard therapy alone. Rivaroxaban/antiplatelet therapy exhibited a higher rate of major bleeding events not associated with coronary artery bypass graft surgery, but "importantly did not increase the risk of fatal bleeding over standard therapy alone", Bayer noted.
The submissions follows approval by the FDA for Xarelto in November to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. The Factor Xa inhibitor was approved in the USA in July for the prevention of venous thromboembolism in adults following elective hip or knee replacement surgery.