October 12, 2018: The U.S. Food and Drug Administration has approved rivaroxaban 2.5 mg twice daily in combination with low-dose aspirin once daily for patients with coronary artery disease or symptomatic peripheral artery disease to reduce the risk of major cardiovascular events (stroke, cardiovascular death, and myocardial infarction).
The U.S. Food and Drug Administration’s approval was based on data from the Phase III COMPASS clinical trial, which demonstrated that rivaroxaban at a vascular dose of 2.5 mg twice daily plus aspirin 100 mg once daily significantly reduced the composite risk of stroke, cardiovascular death, and myocardial infarction by 24% (relative risk reduction) in patients with coronary artery disease or peripheral artery disease, compared with aspirin 100 mg once daily alone.[i]。
“The U.S. Food and Drug Administration’s decision follows closely on the heels of approval by the European Commission and in Canada for rivaroxaban, providing an important new treatment option for patients with coronary artery disease (CAD) and peripheral artery disease (PAD) in the United States,” said Dr. Joerg Moeller, Member of the Executive Committee of Bayer’s Pharmaceuticals Division and Head of Research and Development. “Coronary artery disease and peripheral artery disease have long represented a major public health burden. Event rates have remained high, and, until this approval, no therapy had been shown to definitively reduce event rates in patients with peripheral artery disease. We believe rivaroxaban will meaningfully improve patient outcomes, and we will continue to collaborate with regulatory authorities in other regions around the world to ensure that more patients can benefit from this new therapy.”
References: [i] Eikelboom JW, Connolly SJ, Bosch J, et al. N Engl J Med 2017; 377:1319-1330.