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October 26, 2020

Janssen Seeks New Indication to Expand Use of Xarelto in PAD

October 26, 2020—The Janssen Pharmaceutical Companies of Johnson & Johnson announced it has submitted a supplemental New Drug Application to the FDA for a new indication to expand the use of Xarelto (rivaroxaban) in patients with peripheral artery disease (PAD).

If approved, this new indication for the Xarelto vascular dose (2.5 mg twice daily plus aspirin 75-100 mg once daily) would include reducing the risk of major thrombotic vascular events such as heart attack, stroke, and amputation in patients after recent lower extremity revascularization.

Xarelto, in combination with aspirin, was approved by the FDA in 2018 to reduce the risk of major cardiovascular (CV) events in patients with chronic PAD and coronary artery disease.

According to Janssen, the application is based on data from the VOYAGER PAD study, which showed Xarelto (2.5 mg twice daily) plus aspirin (100 mg once daily) was superior to aspirin alone in reducing the risk of major CV and limb events, with similar rates of Thrombolysis in Myocardial Infarction (TIMI) major bleeding.

The phase 3 VOYAGER PAD study included 6,564 patients from 542 sites across 34 countries worldwide. Patients were randomized in a 1:1 ratio and received either Xarelto (2.5 mg twice daily) plus aspirin (100 mg once daily) (n = 3,286) or aspirin alone (100 mg once daily) (n = 3,278). Patients were stratified by revascularization procedure type (endovascular vs surgical) and use of clopidogrel, which was limited and administered based on the treating physician’s discretion. Patients were followed for a median duration of 28 months.

The primary efficacy endpoint was a composite of major adverse limb and CV events, including acute limb ischemia, major amputation for vascular causes, myocardial infarction, ischemic stroke, or death from CV causes. The principal safety endpoint was major bleeding according to the TIMI classification.

Eligible patients were aged ≥ 50 years and had documented symptomatic lower extremity PAD. Patients were eligible after a successful revascularization for symptomatic PAD within the last 10 days. Approximately two-thirds were treated with an endovascular procedure (65%) and one-third were treated surgically (35%). Patients were excluded if they were clinically unstable, at heightened bleeding risk, or needed prohibited concomitant medications, including long-term clopidogrel. The median age was 67 years, and 26% were women.

On March 28, 2020, results from VOYAGER PAD were presented by Marc P. Bonaca, MD, at the American College of Cardiology’s Annual Scientific Session Together with World Congress of Cardiology (ACC.20/WCC), which was held as a virtual conference.

Janssen and its development partner Bayer AG have conducted two major phase 3 trials, VOYAGER PAD and COMPASS, that evaluated the use of dual antithrombotic pathway inhibition with Xarelto plus aspirin in patients with PAD, advised the company.

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