Xarelto Gets Approval for Additional Indication

Blood thinner med now approved for the reduction of the risk of major cardiovascular events.

Xarelto (rivaroxaban) from Janssen Pharmaceuticals has been on the market as a treatment intended to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. It is an orally bioavailable factor Xa inhibitor that works without the need for a cofactor (such as anti-thrombin III). It selectively blocks the active site of factor Xa.

The U.S. Food and Drug Administration has now granted approval for the use of Xarelto 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). This approval makes the drug the first factor Xa inhibitor approved for this indication.

The FDA’s decision was made considering the results of the COMPASS trial. For patients with chronic CAD and/or PAD, treatment with Xarelto and aspirin resulted in a 24% reduction of the risk of major CV events compared with treatment with aspirin alone. Specifically, a 42% reduction in strokes, 22% reduction in CV deaths and 14% reduction in heart attacks were observed.


Cynthia A. Challener, Ph.D.

Dr. Challener is an established industry editor and technical writing expert in the areas of chemistry and pharmaceuticals. She writes for various corporations and associations, as well as marketing agencies and research organizations, including That’s Nice and Nice Insight.