EU’s EMA approves COMPASS regimen for prevention of CV events in high-risk CAD or PAD patients

News - Sep. 3, 2018

The European Commission (EC) has approved a regimen of 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 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.

Data from the COMPASS study are also currently under review by regulatory authorities globally, and notably by the U.S. Food and Drug Administration (FDA) where it is part of a supplemental New Drug Application (sNDA).

Source: Press release Bayer, August 24, 2018

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