Janssen applies to FDA for New Indication of XARELTO® for Peripheral Artery Disease

The Janssen Pharmaceutical Companies of Johnson & Johnson revealed on Monday the submission of the supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for a new indication to expand the use of XARELTO® (rivaroxaban) in patients with Peripheral Artery Disease (PAD).

Approval of the new indication for XARELTO ® vascular dosage (2.5 mg twice daily plus aspirin 75-100 mg once daily), would potentially significantly decrease the risk of major thrombotic vascular events such as heart attack, stroke and amputation in patients following recent lower-extremity revascularization – a widely used procedure in which blood flow is restored to the legs and feet due to symptomatic PAD.

The application is based on evidence from the VOYAGER PAD report, which demonstrated that XARELTO ® (2.5 mg twice daily) plus aspirin (100 mg once daily) was superior to aspirin alone in minimizing the risk of major cardiovascular (CV) and limb events, with comparable rates of Thrombolysis In Myocardial Infarction (TIMI) major bleeding.

James List, M.D., Ph.D., Global Therapeutic Area Head, Cardiovascular & Metabolism, Janssen Research & Development, LLC commented:

“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. 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.”

Two main Phase 3 trials, VOYAGER PAD and COMPASS, were performed by Janssen and its research partner Bayer, which studied the effectiveness of dual antithrombotic pathway inhibition with XARELTO ® plus aspirin in PAD individuals. In order to minimize the rate of severe CV incidents in patients with chronic PAD and coronary artery disease ( CAD), XARELTO ® was approved by the FDA in 2018 in conjunction with aspirin, the only direct oral anticoagulant (DOAC) approved for use in these groups of patients.

Peripheral Artery Disease is a severe underlying health crisis impacting around 20 million Americans, with only 8.5 million diagnosed. Furthermore, PAD raises the risk of major CV events and is the leading cause of amputation, which almost doubles the risk of mortality.


A total of 6,564 patients from 542 sites across 34 countries worldwide participated in the Phase 3 VOYAGER PAD study. Patients were randomized in a 1:1 ratio and treated with 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). Participants were divided into two groups namely patients who underwent the conventional method of revascularization and participants on conservative non-invasive treatment with the oral anticoagulant clopidogrel, which was administered depending on the treating physician’s discretion. Patients were followed for a median duration of 28 months.

The main effectiveness endpoint was a combination of major adverse limb and CV accidents, including acute limb ischemia, major amputation for vascular causes, heart attack (myocardial infarction), ischemic stroke, or death from CV causes. According to the TIMI classification, the main safety endpoint was major bleeding.

The qualifying patients were age 50 years or older diagnosed with symptomatic lower-extremity Peripheral Artery Disease. Patients were eligible following successful revascularization for symptomatic PAD within the last 10 days. Around two-thirds were treated with an endovascular procedure (65%) and one-third treated surgically (35%). Patients were disqualified if they were clinically unstable, at serious bleeding risk, or needed forbidden concomitant drugs, including long-term clopidogrel. The median age was 67 years and 26% were women. Common risk factors for PAD included diabetes, an estimated glomerular filtration rate less than 60 mL/min/1.73 m2 (indicating mild-to-moderate kidney disease) and current smokers.

About XARELTO® (rivaroxaban)

XARELTO® is a prescription medicine used to reduce the risk of stroke and blood clots in people who have atrial fibrillation that is not caused by a heart valve problem. With atrial fibrillation, part of the heart does not beat the way it should. This can lead to the formation of blood clots, which can travel to the brain, causing a stroke, or to other parts of the body. The medication can be prescribed for treating blood clots in the veins of legs (deep vein thrombosis or DVT) or lungs (pulmonary embolism or PE). It can reduce the risk of blood clots happening again in people who continue to be at risk for DVT or PE after receiving treatment for blood clots for at least 6 months.

XARELTO® may help prevent a blood clot in the legs and lungs of people who have just had hip or knee replacement surgery and help prevent blood clots in certain people hospitalized for an acute illness and after discharge, who are at risk of getting blood clots due to low or no mobility and other risks for getting blood clots, and who do not have a high risk of bleeding.

XARELTO® is used with low dose aspirin to reduce the risk of serious heart problems, heart attack and stroke in people with coronary artery disease or peripheral artery disease.

About Janssen Cardiovascular & Metabolism

In Cardiovascular & Metabolism (CVM), Janssen takes on the most pervasive diseases that burden hundreds of millions of people and healthcare systems around the world. As part of this long-standing commitment and the successes in treating type 2 diabetes and thrombosis, the pharma company advances highly differentiated therapies that prevent and treat life-threatening cardiovascular, metabolic and retinal diseases. Uncovering new therapies that can improve the quality of life for this large segment of the population is an important endeavour – one which Janssen CVM will continue to lead in the years to come. Our mission is global, local and personal.

Please visit www.janssen.com/cardiovascular-and-metabolism

Source: https://www.jnj.com/janssen-submits-application-to-u-s-fda-for-new-indication-to-expand-use-of-xarelto-rivaroxaban-in-patients-with-peripheral-artery-disease


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