FDA Accept Johnson & Johnson’s Expanded Indication for Xarelto

Johnson and Johnson recently announced that FDA approved an expanded peripheral artery disease (PAD) indication for its Xarelto vascular dose.

The indication will now include patients following recent lower-extremity revascularization due to symptomatic PAD. 

Xarelto is the first and only therapy to help reduce the risks of major cardiovascular and thrombotic vascular events in patients with coronary artery disease, including myocardial infarction, ischemic stroke, and major amputation of a vascular etiology in patients with PAD. 

“We’re thrilled to bring XARELTO to even more patients with PAD who have been living for two decades without any new innovation in the antithrombotic space,” James List, MD, PhD, global therapeutic area head of cardiovascular and metabolism at Janssen Research & Development, said in the announcement. 

FDA based its approval on results from the Phase 3 VOYAGER PAD study, which enrolled 6,564 patients from 542 sites across 34 countries worldwide. Patients were randomized to receive either Xarelto 2.5 milligrams twice daily plus aspirin 100 milligrams once daily or aspirin alone. 

In the study, Xarelto vascular dose reduced the risk of major adverse limb and cardiovascular events 15 percent in patients with symptomatic PAD after lower-extremity revascularization. 

Researchers also found significant benefit from adding Xarelto to aspirin, which was consistent throughout the study. 

Currently, nearly 20 million Americans live with PAD, but just 8.5 million are diagnosed, a Johnson and Johnson spokesperson said. PAD is frequently missed due to a lack of awareness and other health conditions that may take priority.

PAD is the leading cause of amputations in the US and results in high fatal and non-fatal CV events.

Marc P. Bonaca, MD, MPH, department of medicine and division of cardiovascular medicine at the University of Colorado Anschutz Medical Campus, stated many physicians have used dual antiplatelet therapy after lower extremity revascularization due to symptomatic PAD for years, but with limited data to support efficacy and safety in this setting.

“These data provide a new mechanism of treatment using an evidence-based strategy for this vulnerable population,” Bonaca said. “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.”

Xarelto now has nine indications in the US, the most of any direct oral anticoagulant.