Janssen’s Xarelto Approved by FDA for Expanded Indication for Patients After Lower Extremity Revascularization to Treat Symptomatic PAD

August 24, 2021—The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the FDA has approved an expanded peripheral artery disease (PAD) indication for Xarelto (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) to include patients after recent lower extremity revascularization (LER) to treat symptomatic PAD.

Janssen advised that the approval is based on data from the phase 3 VOYAGER PAD trial, which saw no significant difference in Thrombolysis in Myocardial Infarction major bleeding between Xarelto with aspirin compared to aspirin alone. The results from the VOYAGER PAD study complement findings from the landmark phase 3 COMPASS trial, which also examined the dual pathway approach of Xarelto with aspirin in coronary artery disease (CAD) and/or PAD patients and further supports this FDA label extension in PAD patients.

According to the company, Xarelto is now indicated to help reduce the risks of major cardiovascular events in patients with CAD and major thrombotic vascular events, such as myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation of a vascular etiology, in patients with PAD, including patients who have recently undergone LER for symptomatic PAD.

“For more than 20 years, many physicians have used dual antiplatelet therapy after LER due to symptomatic PAD with limited data to support efficacy and safety in this setting,” commented Marc P. Bonaca, MD, in the Janssen press 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.”

Dr. Bonaca added, “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.” Dr. Bonaca is from the Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus in Aurora, Colorado.