New Indication for Rivaroxaban Approved By FDA

Janssen's Xarelto (rivaroxaban) is now indicated for reducing the risk of major cardiovascular events, such as death, myocardial infarction, and stroke, in people with chronic coronary or peripheral artery disease.

A new indication for Janssen’s rivaroxaban (Xarelto) has been approved by FDA officials.

First approved by the FDA in 2011, the oral anticoagulant is now indicated for reducing the risk of major cardiovascular (CV) events, such as death, myocardial infarction (MI), and stroke, in people with chronic coronary or peripheral artery disease (CAD/PAD). The agency’s approval makes Xarelto the first and only Factor Xa inhibitor with the FDA’s backing for patients living with these conditions, according to Janssen.

“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, and Vice President of Medical Affairs, Internal Medicine, Janssen Scientific Affairs, LLC, in a prepared statement. “The new Xarelto vascular 2.5mg dose, when used with aspirin, represents a true breakthrough for patients with chronic CAD and PAD.”

The new indication is based on results from the COMPASS Phase 3 clinical trial that studied 27,395 patients with CAD or PAD, in 33 countries. The results showed a significant 24% reduction of the risk of major CV events in patients with chronic CAD and/or PAD with the Xarelto 2.5mg vascular dose twice daily, plus aspirin 100 mg once daily, as compared to use of aspirin alone. According to Janssen, this finding was driven by 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 combination, compared to aspirin alone, with no significant increase in fatal or intracranial bleeds.

In a prepared statement, Kelley Branch, MD, MSc, FACC, FSCCT, Associate Professor in Cardiology at the University of Washington, Seattle, said that using only aspirin to treat patients with the underlying thrombotic risk that comes with chronic CAD and PAD is not enough. “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 of CV events in these populations,” said Branch.

According to Janssen, patients who take rivaroxaban have an increased risk of bleeding, and may bruise more easily than without the drug.

Xarelto has been approved by the FDA for a variety of indications since it first arrived on the market.

Peer Exchange: Considerations for Using NOAC Reversal Agents


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) [news release]. Titusville, NJ; October 11, 2018: Janssen Pharmaceuticals website. Accessed October 12, 2018.

Related Videos
Credit: wladimir1804 -
Women buying contraceptive pills in the pharmacy | Image credit: Antonioguillem -
Healthcare technology | Image credit: ipopba |
Gastroenterologist using digital x-ray of human intestine holographic scan projection 3D rendering | Image Credit: sdecoret -
Supreme Court | Image credit: steheap -
Pharmacists talking with a nurse | Image credit: Jacob Lund -
Healthcare technology | Image credit: ipopba |
© 2023 MJH Life Sciences

All rights reserved.