JOHNSON & JOHNSON
The Janssen Pharmaceutical Companies of
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, a common procedure in which blood flow is restored to the legs and feet due to symptomatic PAD. 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 cardiovascular (CV) and limb events, with similar rates of Thrombolysis In Myocardial Infarction (TIMI) major bleeding.
'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
Janssen and its development partner Bayer 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. XARELTO, in combination with aspirin, was approved by the FDA in 2018 to reduce the risk of major CV events in patients with chronic PAD and coronary artery disease (CAD) - the only direct oral anticoagulant (DOAC) approved for use in these populations.
PAD is a serious underlying health crisis that impacts an estimated 20 million Americans, with only 8.5 million diagnosed.[i],[ii] PAD also increases the risk for major CV events and is the leading cause of amputation,[iii] which can double a patient's risk of death.[iv]
About VOYAGER PAD
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, heart attack (myocardial infarction), ischemic stroke, or death from CV causes. The principal safety endpoint was major bleeding according to the TIMI classification.
Eligible patients were at least 50 years old 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 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. 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.
WHAT IS XARELTO (rivaroxaban)
XARELTO is a prescription medicine used to: reduce the risk of stroke and blood clots in people who have a medical condition called 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 treat blood clots in the veins of your legs (deep vein thrombosis or DVT) or lungs (pulmonary embolism or PE) 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 help prevent a blood clot in the legs and lungs of people who have just had hip or knee replacement surgery help prevent blood clots in certain people hospitalized for an acute illness and after discharge, who are at risk of getting blood clots because of the loss of or decreased ability to move around (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 (a condition where the blood supply to the heart is reduced or blocked) or peripheral artery disease (a condition where the blood flow to the legs is reduced) It is not known if XARELTO is safe and effective in children.
IMPORTANT SAFETY INFORMATION
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT XARELTO
XARELTO may cause serious side effects, including:
Increased risk of blood clots if you stop taking XARELTO. People with atrial fibrillation (an irregular heart beat) that is not caused by a heart valve problem (nonvalvular) are at an increased risk of forming a blood clot in the heart, which can travel to the brain, causing a stroke, or to other parts of the body. XARELTO lowers your chance of having a stroke by helping to prevent clots from forming. If you stop taking XARELTO, you may have increased risk of forming a clot in your blood.
Do not stop taking XARELTO without talking to the doctor who prescribes it for you. Stopping XARELTO increases your risk of having a stroke. If you have to stop taking XARELTO, your doctor may prescribe another blood thinner medicine to prevent a blood clot from forming.
Increased risk of bleeding. XARELTO can cause bleeding which can be serious, and may lead to death. This is because XARELTO is a blood thinner medicine (anticoagulant) that lowers blood clotting. During treatment with XARELTO you are likely to bruise more easily, and it may take longer for bleeding to stop. You may be at higher risk of bleeding if you take XARELTO and have certain other medical problems.
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