The European Commission approved the oral anticoagulant rivaroxaban for the prevention of atherothrombotic events after an acute coronary syndrome (ACS) in adult patients with elevated cardiac biomarkers.

In March, the European Union’s Committee for Medicinal Products for Human Use adopted the new indication for a new strength of rivaroxaban (Xarelto, Janssen Pharmaceuticals/Bayer HealthCare). The approval specifies the use of rivaroxaban at a dose of 2.5 mg twice-daily (BID) in combination with standard antiplatelet therapy.

Berlin-based Bayer HealthCare said that approval of rivaroxaban was based on findings from the ATLAS ACS 2-TIMI 51 study (Anti-Xa Therapy to Lower cardiovascular events in Addition to aspirin with/without thienopyridine therapy in Subjects with Acute Coronary Syndrome), which evaluated the efficacy of rivaroxaban compared to placebo in preventing cardiovascular death, MI or stroke in patients after an ACS. The study showed a mortality benefit when adding rivaroxaban to dual-antiplatelet therapy.

Rivaroxaban is a factor Xa inhibitor. The 10mg dose already has been approved in the EU for prevention of venous thromboembolism in adults undergoing elective hip or knee replacement surgery; and 15mg and 20mg doses for the prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation with one or more risk factors and treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.  

“We know that thrombin levels remain elevated long after an ACS event, leaving patients at risk,” C. Michael Gibson, MD, a cardiologist at Beth Israel Deaconess Medical Center in Boston and principal investigator in the ATLAS ACS studies, said in a release. “In the ATLAS ACS 2-TIMI 51 study, we’ve shown that treating these patients with a low dose of rivaroxaban in combination with standard antiplatelet therapy targets both pathways of clot formation providing more complete long-term protection, including significant reduction in mortality risk.”

In the U.S., the FDA has given a cold shoulder to rivaroxaban for the reduction of the risk of cardiovascular events in patients with ACS. In March, the agency issued a second complete response letter on a supplemental New Drug Application.