Janssen Pharmaceutical announced the U.S. Food and Drug Administration (FDA) has approved Xarelto (rivaroxaban) to reduce the risk of major cardiovascular (CV) events, such as CV death, myocardial infarction (MI) and stroke, in people with chronic coronary or peripheral artery disease (CAD/PAD). Xarelto is now the first and only Factor Xa inhibitor approved for patients living with these conditions.
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This new indication is based on results from the landmark COMPASS trial, which showed a significant 24% reduction of the risk of major CV events in patients with chronic CAD and/or PAD with the Xarelto 2.5-mg vascular dose twice daily plus aspirin 100 mg once daily, compared to aspirin alone. This finding was driven by a 42% reduction in stroke, 22% reduction in CV death and 14% reduction in heart attack. The risk of major bleeding was significantly higher in patients taking the Xarelto/aspirin regimen compared to aspirin alone, with no significant increase in fatal or intracranial bleeds.
"Despite the use of guideline-recommended therapies, patients with chronic CAD and/or PAD remain at risk of having a devastating and irreversible CV event," said Paul Burton, MD, PhD, FACC, Vice President, Medical Affairs, Internal Medicine, Janssen Scientific Affairs, LLC. "The new Xarelto vascular 2.5-mg dose, when used with aspirin, represents a true breakthrough for patients with chronic CAD and PAD."