CHMP recommends Xarelto to prevent atherothrombotic events in adult patients with coronary artery disease or symptomatic peripheral artery disease. - Bayer + Janssen.

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 Bayer´s oral Factor Xa inhibitor Xarelto (rivaroxaban). The regimen of Xarelto 2.5 mg twice daily plus acetylsalicylic acid (ASA) 75 – 100 mg once daily will be indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) 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, 2.5 mg twice daily, plus ASA 100 mg once daily reduced the risk of the composite of stroke, cardiovascular (CV) death and heart attack by 24% (relative risk reduction) compared with ASA 100 mg once daily alone in patients with CAD or PAD.