03/05/2023 | Press release | Distributed by Public on 03/05/2023 10:04
TITUSVILLE, NJ,March 5, 2023 - The Janssen Pharmaceutical Companies of Johnson & Johnson today announced data from a new prespecified analysis from the Phase 3 VOYAGER PAD clinical trial reinforcing the benefits of the XARELTO® (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) over standard of care (aspirin alone), demonstrating consistent benefit at 30 days, 90 days and up to three years following LER in patients with PAD. Lower extremity revascularization, also called peripheral revascularization, is a procedure that restores blood flow in blocked arteries or veins. This analysis of the VOYAGER PAD study showed XARELTO® plus aspirin resulted in a 33 percent reduction in acute limb ischemia and a 15 percent reduction in major adverse limb and cardiovascular events, with or without dual antiplatelet therapy (DAPT). These latest XARELTO® data were presented at the American College of Cardiology's 72nd Annual Scientific Session (ACC.23), hosted in New Orleans, Louisiana, March 4-6, 2023.
"These data demonstrate an evolution in the medical therapy of patients undergoing lower extremity revascularization for symptomatic peripheral artery disease, where the addition of low dose rivaroxaban to antiplatelet therapy results in a 33 percent reduction in major adverse limb events both early and late and with a consistently favorable benefit risk," said Marc P. Bonaca**, M.D., Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado. "We hope these data assist clinicians in understanding how to implement antithrombotic therapy in practice and overall support initiation of rivaroxaban in the first days after revascularization regardless of whether or not DAPT is utilized."
Following LER, patients with PAD are four times more likely to experience acute limb ischemia, or a rapid decrease in lower limb blood flow,which is often associated with long hospitalizations and high incidences of amputation, disability, and death unless appropriate treatment is given.1 Those treated with XARELTO® plus aspirin after LER saw a 33 percent reduction in acute limb ischemia, with a trend toward greater benefit observed early (≤30 days HR=0.45; 95% CI, 0.24-0.85) versus late (>90 days HR=0.75; 95% CI 0.60-0.95). XARELTO® plus aspirin was more effective than antiplatelet therapy alone in preventing acute limb ischemia after LER (Kaplan-Meier estimate from 0 to 90 days 1.02% vs. 2.10%, respectively, and 4.3% and 5.7% from 91 days to three years). The hazard ratio for the rate of thrombolysis in myocardial infarction (TIMI) major bleeding at 0 to 90 days was HR 2.01 (range 0.9-4.47) and from days 91 up to three years was HR 1.28 (range 0.82-1.99), neither of which were statistically significant.
"These findings provide additional insights on the proven clinical utility of XARELTO® for people living with PAD, particularly those who have undergone lower extremity revascularization," said Avery Ince, M.D., Ph.D., Vice President, Medical Affairs, Cardiovascular & Metabolism, Janssen Scientific Affairs, LLC. "At Janssen, we remain steadfast in our commitment to advance science that can transform cardiovascular care for all."
In August 2021, the U.S. Food and Drug Administration (FDA) approved an expanded PAD indication for the XARELTO® vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) to include patients following a recent LER due to symptomatic PAD. The XARELTO® vascular dose is the first and only approved anticoagulant for PAD. XARELTO® acts on a dual pathway inhibition (DPI) approach to target both clotting mechanisms, thrombin and platelet activation.
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 the XARELTO® vascular dose (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 administered at the treating physician's discretion. Patients were followed for a median of 28 months.
The VOYAGER PAD study met its primary efficacy and principal safety endpoints, demonstrating the XARELTO® vascular dose was superior to aspirin alone in reducing the risk of major adverse limb and cardiovascular events (composite outcome of acute limb ischemia, major amputation for vascular causes, myocardial infarction, ischemic stroke, or cardiovascular death) by 15 percent in patients with symptomatic PAD after lower-extremity revascularization. The benefit of adding XARELTO® to aspirin was apparent early, was consistent among major subgroups and continued to accrue over time. There was no significant increase in thrombolysis in myocardial infarction (TIMI) major bleeding observed in patients treated with the XARELTO® vascular dose compared to aspirin alone (Kaplan-Meier estimate at three years 2.65% vs. 1.87%, respectively).
About XARELTO® (rivaroxaban)
XARELTO® is a prescription medicine used to:
XARELTO® is used with low dose aspirin to:
XARELTO® is used in children to:
XARELTO® was not studied and is not recommended in children less than 6 months of age who:
IMPORTANT SAFETY INFORMATION
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT XARELTO®?
XARELTO® may cause serious side effects, including:
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.
You may have a higher risk of bleeding if you take XARELTO® and take other medicines that increase your risk of bleeding, including:
Tell your doctor if you take any of these medicines. Ask your doctor or pharmacist if you are not sure if your medicine is one listed above.
Call your doctor or get medical help right away if you or your child develop any of these signs or symptoms of bleeding:
If you take XARELTO® and receive spinal anesthesia or have a spinal puncture, your doctor should watch you closely for symptoms of spinal or epidural blood clots.
Tell your doctor right away if you have:
XARELTO® is not for use in people with artificial heart valves.
XARELTO® is not for use in people with antiphospholipid syndrome (APS), especially with positive triple antibody testing.
Do not take XARELTO® if you or your child:
Before taking XARELTO®, tell your doctor about all your medical conditions, including if you or your child:
Tell all of your doctors and dentists that you or your child are taking XARELTO®. They should talk to the doctor who prescribed XARELTO® for you before you have any surgery, medical or dental procedure.
Tell your doctor about all the medicines you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Some of your other medicines may affect the way XARELTO® works, causing side effects. Certain medicines may increase your risk of bleeding. See "What is the most important information I should know about XARELTO®?"
HOW SHOULD I TAKE XARELTO®?
If you take XARELTO® for:
Reducing the risk of a sudden decrease in blood flow to the legs, major amputation, serious heart problems or stroke in people with peripheral artery disease, including those who have recently had a procedure to improve blood flow to the legs:
For children who take XARELTO®:
if vomiting or spitting up persists, contact your child's doctor right away.
If your child misses a dose:
WHAT ARE THE POSSIBLE SIDE EFFECTS OF XARELTO®?
XARELTO® may cause serious side effects:
The most common side effect of XARELTO® in adults was bleeding.
The most common side effects of XARELTO® in children include:
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Janssen Pharmaceuticals, Inc., at 1-800-JANSSEN (1-800-526-7736).
Please read full Prescribing Information, including Boxed Warnings, and Medication Guide for XARELTO®.
Trademarks are those of their respective owners. Janssen and Bayer together are developing rivaroxaban.
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular, Metabolism & Retina; Immunology; Infectious Diseases & Vaccines; Neuroscience; Oncology; and Pulmonary Hypertension.
Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenUSand https://twitter.com/JanssenGlobal. Janssen Scientific Affairs, LLC, is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of rivaroxaban. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Scientific Affairs, LLC, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2023, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
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* Reduction of a composite of myocardial infarction, ischemic stroke, acute limb ischemia and major amputation of a vascular etiology.
** Dr. Marc Bonaca is the lead study author of the VOYAGER PAD analysis entitled "Consistent Benefit of Rivaroxaban Early and Late after Lower Extremity Revascularization" and was provided payment for his participation in the study; he has not been compensated for contributing to this press release.