European Commission approves Xarelto + aspirin to prevent atherothrombotic events.- Bayer HealthCare + Janssen Pharma.

The European Commission (EC) has approved a regimen of Xarelto (rivaroxaban) 2.5 mg twice daily plus acetylsalicylic acid (ASA) 75-100 mg once daily for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk for ischemic events. The first country where Xarelto is planned to become available for these patients is Germany.

The EU approval is based on data from the Phase III COMPASS study, which showed that rivaroxaban vascular dose, 2.5 mg twice daily, plus ASA 100 mg once daily reduced the risk of the composite of stroke, cardiovascular death and heart attack by 24% (relative risk reduction) compared with ASA 100 mg once daily alone in patients with CAD or PAD.

�Despite many advances in the area of cardiovascular care, CAD and PAD have remained an area of unmet need. Even with currently available treatments for secondary prevention, patients remain at an unacceptable high risk of thrombotic events which can lead to disability, loss of limb and death,� said Professor John Eikelboom, Associate Professor, Division of Hematology & Thromboembolism, Department of Medicine, McMaster University, Canada. �The approval of this combination approach of the vascular dose of an anticoagulant plus an antiplatelet provides physicians and patients with a much-needed improved treatment option.�