Rivaroxaban gets FDA approval for treatment in CAD or PAD

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Rivaroxaban, brand name Xarelto (Janssen), has received approval by the US Food and Drug Administration (FDA) to reduce the risk of major cardiovascular (CV) events, such as CV death, myocardial infarction and stroke, in people with chronic coronary or peripheral arterial disease (CAD/PAD). Rivaroxaban is now the first and only Factor Xa inhibitor approved for patients living with these conditions.

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 a 2.5mg vascular dose of rivaroxaban twice daily plus aspirin 100mg 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 rivaroxaban/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, vice president, Medical Affairs, Internal Medicine, Janssen Scientific Affairs, LLC. “The new Xarelto vascular 2.5mg dose, when used with aspirin, represents a true breakthrough for patients with chronic CAD and PAD.”

“Treating patients with aspirin only is simply not enough to address the underlying thrombotic risk that comes with chronic CAD and PAD,” said Kelley Branch, associate professor in Cardiology, University of Washington, Seattle, USA. “As we saw in the COMPASS trial, the dual pathway approach of aspirin and the 2.5mg, twice-daily dose of Xarelto can help significantly reduce the risk of CV events in these populations.”

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