Posted by Michael Wonder on 27 Aug 2018
Bayer secures approval in the EU for Xarelto (rivaroxaban) for patients with coronary or peripheral artery disease
24 August 2018 - Xarelto is the only non-vitamin K antagonist oral anti-coagulant indicated in combination with aspirin for the prevention of atherothrombotic events in patients with coronary artery disease or symptomatic peripheral artery disease at high risk for ischaemic events.
The European Commission has approved a regimen of Xarelto (rivaroxaban) 2.5 mg twice daily plus aspirin 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 ischaemic 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 aspirin 100 mg once daily reduced the risk of the composite of stroke, cardiovascular death and heart attack by 24% (relative risk reduction) compared with aspirin 100 mg once daily alone in patients with CAD or PAD.
