FDA Approves Rivaroxaban for a New Indication

The US Food and Drug Administration (FDA) has approved rivaroxaban to reduce the risk for major cardiovascular (CV) events. The move makes rivaroxaban the only Factor Xa inhibitor to be approved for patients with CV conditions.

The approval comes after results from the recent COMPASS trial, which showed that patients with chronic coronary artery disease (CAD) and peripheral artery disease (PAD) who took a 2.5-mg vascular dose of rivaroxaban twice a day—along with 100 mg of aspirin once a day—had a 24% reduction of the risk for major CV events.

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The trial’s findings also showed a 42% reduction in stroke, a 22% reduction in CV death, and a 14% reduction in myocardial infarction.

Paul Burton, MD, vice president of Medical Affairs and Internal Medicine for Janssen Scientific Affairs, LLC, called the findings and their subsequent FDA approval “a true breakthrough for patients with chronic CAD and PAD.”

Patients taking both rivaroxaban and aspirin had a significantly higher risk for major bleeding when compared with patients taking just aspirin, but there was no significant increase in fatal or intracranial bleeds.

“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, MD, associate professor in cardiology at University of Washington, Seattle. “As we saw in the COMPASS trial, the dual pathway approach of aspirin and the 2.5-mg, twice-daily dose of XARELTO can help significantly reduce the risk for CV events in these populations.”

—Colleen Murphy

Reference:

U.S. FDA approves XARELTO® (rivaroxaban) to reduce the risk of major cardiovascular events in patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD) [press release]. Titusville, NJ: Janssen Pharmaceutical Companies; October 11, 2018. https://www.janssen.com/us-fda-approves-xareltor-rivaroxaban-reduce-risk-major-cardiovascular-events-patients-chronic. Accessed October 15, 2018.