FDA approves Xarelto to reduce the risk of CV events.- Bayer Healthcare + Janssen
The FDA has approved rivaroxaban (Xarelto), 2.5 mg twice daily, plus aspirin low dose once daily to reduce the risk of major cardiovascular events including cardiovascular (CV) death, heart attack or stroke in patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD).
The FDA 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, CV death and heart attack by 24% (relative risk reduction) compared with aspirin 100 mg once daily alone in patients with CAD or PAD.
Comment:The drug is the is the first and only Factor Xa inhibitor approved to reduce the risk of major cardiovascular events in people with chronic coronary or peripheral artery disease (CAD or PAD).
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