Janssen Submits sNDA to FDA for Expanded Use of Rivaroxaban in Patients with Peripheral Artery Disease


Janssen Pharmaceutical Companies submitted a supplemental New Drug Application (sNDA) to the FDA to expand the use of rivaroxaban in patients with peripheral artery disease.

Janssen Pharmaceutical Companies submitted a supplemental New Drug Application (sNDA) to the FDA to expand the use of rivaroxaban in patients with peripheral artery disease (PAD).

If this expansion is approved by the FDA, the new indication for rivaroxaban’s vascular dose, which is 2.5 mg twice daily with 75 to 100 mg of aspirin once daily, would also be used to reduce the risk of major thrombotic vascular events. Such events include heart attack, stroke, and amputation for patients following lower-extremity revascularization, which is a procedure that restores blood flow to the legs and feet for patients with PAD.

PAD is a disease that affects the lives of approximately 20 million Americans, with only 8.5 million people currently diagnosed in the United States. PAD can also increase the risk of major cardiovascular (CV) events in patients, and is the leading cause of amputation. For patients with PAD, amputation can double the risk of death.

In the recent VOYAGER PAD study, researchers found that rivaroxaban given at 2.5 mg twice daily with aspirin at 100 mg once daily was more effective than aspirin by itself in the reduction of major CV and limb event risk for patients with PAD. The study also demonstrated similar rates of thrombolysis in myocardial infarction (TIMI) major bleeding among these 2 treatments.

"Various antithrombotic regimens have been evaluated for short- and long-term prevention of major vascular events in patients with PAD, but only rivaroxaban in combination with aspirin has demonstrated a significant benefit over aspirin alone," said James List, MD, PhD, the global therapeutic area head of cardiovascular and metabolism at Janssen Research & Development, LLC, in a press release. "Data from the VOYAGER PAD trial were the first in 20 years to show clinical benefit with an antithrombotic therapy in the symptomatic PAD population after lower-extremity revascularization, which speaks to the need for a new treatment in this space. We look forward to discussing these data with the FDA."

In order to investigate the efficacy of rivaroxaban with aspirin in the treatment of patients with PAD, 2 phase 3 trials, VOYAGER PAD and COMPASS, have been conducted to evaluate the use of dual antithrombotic pathway inhibition with the combination treatment. In 2018, rivaroxaban in combination with aspirin had been approved by the FDA for reducing the risk of major CV events in patients with chronic PAD and coronary artery disease. Currently, this combination treatment is the only direct oral anticoagulant approved for use with these patients.


Janssen Submits Application to U.S. FDA for New Indication to Expand Use of XARELTO® (rivaroxaban) in Patients with Peripheral Artery Disease. Raritan, NJ: Janssen Pharmaceutical Companies; October 26, 2020. janssen.com/janssen-submits-application-us-fda-new-indication-expand-use-xarelto-rivaroxaban-patients. Accessed November 6, 2020.

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