FDA Okays New PAD Indication for Rivaroxaban (Xarelto)

Megan Brooks

August 24, 2021

The US Food and Drug Administration (FDA) has approved an expanded peripheral artery disease (PAD) indication for the direct oral anticoagulant rivaroxaban (Xarelto) to include patients who have undergone recent lower-extremity revascularization due to symptomatic PAD.

The approved regimen in this patient population is rivaroxaban 2.5 mg twice daily with aspirin 100 mg once daily, Janssen Pharmaceuticals/Johnson & Johnson said in a news release.

Rivaroxaban with aspirin is the first and only treatment indicated for both coronary artery disease (CAD) and PAD, including now PAD patients who have undergone lower-extremity revascularization, the company said.

"For more than 20 years, many physicians have used dual antiplatelet therapy after lower extremity revascularization due to symptomatic PAD with limited data to support efficacy and safety in this setting," Marc P. Bonaca, MD, University of Colorado Anschutz Medical Campus, Aurora, said in news release.

"Now, the VOYAGER PAD and COMPASS clinical studies have demonstrated the utility of dual pathway inhibition in targeting both platelets and thrombin in patients with PAD. These data provide a new mechanism of treatment using an evidence-based strategy for this vulnerable population," said Bonaca.

In the VOYAGER PAD study of patients with PAD who had undergone lower-extremity revascularization, rivaroxaban 2.5 mg twice daily plus aspirin was associated with a significantly lower incidence of the composite outcome of acute limb ischemia, major amputation for vascular causes, myocardial infarction, ischemic stroke, or death from cardiovascular causes than aspirin alone, as reported by theheart.org | Medscape Cardiology.

In the COMPASS trial, rivaroxaban 2.5 mg twice daily plus aspirin was associated with a reduction in ischemic events and mortality and a superior net clinical benefit, balancing ischemic benefit with severe bleeding, compared with aspirin alone, for secondary prevention in patients with stable atherosclerotic vascular disease.

"This FDA approval of rivaroxaban plus aspirin is a major advancement for PAD management and sets the stage to evolve the current standard of care for patients with PAD," Bonaca said.

Rivaroxaban now has nine indications in the United States, the most of any direct oral anticoagulant.


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