The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for a new indication of the oral Factor Xa inhibitor rivaroxaban (Xarelto, Bayer). The regimen of rivaroxaban 2.5mg twice daily plus aspirin 75–100mg once daily will be indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease at high risk for ischaemic events.
The positive opinion is based on data from the COMPASS study, the largest Phase III study with rivaroxaban (27,395 patients), which showed that the rivaroxaban vascular dose, 2.5mg twice daily, plus aspirin 100mg once daily reduced the risk of the composite of stroke, cardiovascular death and heart attack by 24% (relative risk reduction) compared with aspirin 100mg once daily alone in patients with coronary artery disease or peripheral arterial disease.
Joerg Moeller, member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Head of Research and Development, says: “Despite the use of Guideline recommended therapies for patients with coronary artery disease and peripheral arterial disease, event rates—including heart attack, stroke or even death—remain high. The positive CHMP opinion takes us one step closer to providing these patients with an important new treatment option.”
Once approved, rivaroxaban will be the only non-vitamin K antagonist oral anticoagulant (NOAC) indicated in combination with aspirin for the prevention of atherothrombotic events in adult patients with coronary artery disease or symptomatic peripheral artery disease at high risk for ischaemic events.
As well as demonstrating a significant reduction in the composite efficacy endpoint of major adverse cardiovascular events (MACE), data from the COMPASS study showed that the rivaroxaban vascular dose, 2.5 mg twice daily, plus ASA 100 mg once daily resulted in a significant reduction in stroke (42%) and CV death (22%) compared to ASA 100 mg once daily alone (relative risk reduction). Furthermore, the combination regimen was associated with a 20% improvement in net clinical benefit, defined as the reduction in stroke, cardiovascular death, and heart attack balanced against the most serious bleeding events.
Bleeding incidence rates were low, and while there was an increase in major bleeding, notably there was no significant increase in fatal or intracranial bleeding.