New VOYAGER PAD Analyses Reinforce Benefit of XARELTO … – PR Newswire

Data presentations at AHA 2023 Meeting reinforce treatment with XARELTOplus aspirin consistently reduces major cardiovascular events (MACE) as well as major adverse limb events (MALE) in complex patients with PAD

Janssen continues commitment to supporting PAD patients with ongoing research to help understand this undertreated and underdiagnosed disease1

TITUSVILLE, N.J., Nov. 14, 2023 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced data from two new analyses from the Phase 3 VOYAGER PAD clinical trial reinforcing the benefit of XARELTO (rivaroxaban [2.5 mg twice daily plus aspirin 100 mg once daily]) over standard of care (aspirin alone). Data from the two analyses demonstrate the role of XARELTO in treating both high-risk and fragile patients and those with and without comorbid coronary artery diseases (CAD). Results were presented at the American Heart Association's (AHA) 2023 Scientific Sessions, hosted in Philadelphia, Pennsylvania, November 11-13, 2023.

"These analyses reinforce the consistency of the favorable benefit-risk profile of XARELTO plus aspirin for patients with vascular disease, regardless of comorbidity. For example, patients categorized as 'fragile' are often undertreated due to concerns about benefit-risk, particularly with antithrombotic treatments," said Marc P. Bonaca*, M.D., Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado."We hopethe ongoing wealth of data coming from VOYAGER PADpresented at AHA offers clinicians the information they need to support shared decision-making in prescribing XARELTOplus aspirin as the standard of care for their PAD patients, including those who are high-risk or complex."

Impact of XARELTO plus Aspirin on Total Vascular Events in Fragile Patients with PAD

Fragile patients with PAD can be at a heightened risk for MALE, defined as a composite of acute limb ischemia (ALI) and major amputation. In this analysis, fragile patients are defined as age greater than 75 years, or weight less than 50 kg or baseline eGFR less than 50 mL/min/1.732.XARELTO plus aspirin(2.5 mg twice daily plus aspirin 100 mg once daily) was shown to be effective in reducing the occurrence of MALEin both fragile and non-fragile patients, compared to placebo (aspirin alone). In fragile patients treated with XARELTO plus aspirin, 6.2% of patients experienced a MALE compared to 10.3% of patients treated with placebo. In non-fragile patients, 7.9% of patients treated with XARELTO plus aspirin experienced a MALE compared to 9.7% of patients treated with placebo.

XARELTO plus aspirin also reduced the occurrence of total vascular events in fragile patients over time, with an absolute rate of 82.1 events per 100 patients at three years compared to 99.3 events per 100 patients in those treated with placebo at three years. A similar benefit was also seen in non-fragile patients, with a rate of 70.4 events per 100 patients at three years in those treated with XARELTO plus aspirin compared to 81.6 events per 100 patients in those treated with placebo at three years. Importantly, thrombolysis in myocardial infarction (TIMI) major bleeding was consistent in both the fragile and non-fragile treatment groups. XARELTO plus aspirin demonstrated a consistent, numerical increase in TIMI major bleeding for both the fragile (HR 1.66; 95% CI 0.87-3.19) and the non-fragile (HR 1.37; 95% CI 0.83-2.24, p-interaction 0.65) patients.

Role of XARELTO Plus Aspirin on Myocardial Infarction in Patients with PAD with and without Concomitant CAD Following Lower Extremity Revascularization (LER)

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.2 Patients with PAD are also at a heightened risk of MACE, defined as myocardial infarction (MI), ischemic stroke, or cardiovascular death. In this analysis, 14.1% of patients with PAD and CAD treated with XARELTO plus aspirin experienced a MACE versus 17.6% of patients treated with placebo (aspirin alone). In patients with PAD only, 11% of patients treated with XARELTO plus aspirin experienced a MACE versus 9.8% of patients treated with placebo. Overall, XARELTO plus aspirin showed a consistent benefit in reducing MACE in patients with and without CAD.

In this analysis, patients with CAD (HR 2.23; CI 1.10-4.53) and patients without CAD (HR 1.15; CI 0.72-1.84) had higher rates of TIMI major bleeding with XARELTO plus aspirin compared to placebo plus aspirin. The rates of intracerebral hemorrhage (ICH) and fatal bleeding were similar across both patient groups. Overall, the safety of XARELTO plus aspirin in patients with PAD was consistent regardless of CAD with no significant interactions.

"At Janssen, we work tirelessly to bring the latest research and clinical practice insights to healthcare providers and their patients to help improve cardiovascular care for all," said Avery Ince, M.D., Ph.D., Vice President, Medical Affairs, Cardiovascular & Metabolism, Janssen Scientific Affairs, LLC. "These new findings continue to support the use of XARELTO with its positive benefit-risk profile in many types of patients, including those who are high-risk and considered harder to treat."

In August 2021, the U.S. Food and Drug Administration (FDA) approved an expanded PAD indication for XARELTO(2.5 mg twice daily plus aspirin 75 - 100 mg once daily) to include patients following a recent LER due to symptomatic PAD. XARELTOacts on a dual pathway inhibition (DPI) approach to target both clotting mechanisms, thrombin and platelet activation.

About VOYAGER PADThe 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 (rivaroxaban [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 plus aspirin 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 plus aspirin 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 doctorif 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 doctorright 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:

For children who take XARELTO:

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 XARELTOin 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 Guidefor XARELTO.

Trademarks are those of their respective owners. Janssen and Bayer together are developing rivaroxaban.

About the Janssen Pharmaceutical Companies of Johnson & JohnsonAt 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: Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension and Retina.

Learn more at http://www.janssen.com. Follow us at @JNJInnovMedand @JanssenUSJanssen Scientific Affairs, LLC,is a Johnson & Johnson company.

Cautions Concerning Forward-Looking StatementsThis 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 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 http://www.sec.gov, http://www.jnj.com or on request from Johnson & Johnson. None of Janssen Scientific Affairs, LLC nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

References

*Dr. Marc Bonaca is the lead study author of the VOYAGER PAD analysis entitled "Impact of Low-dose Rivaroxaban plus Aspirin on Total Vascular Events in Fragile Patients with Peripheral Artery Disease: Insights from VOYAGER PAD" and "Impact of Low-dose Rivaroxaban plus Aspirin on Myocardial Infarction in Patients with Peripheral Artery Disease with and without Concomitant Coronary Artery Disease: Insights from VOYAGER PAD," and was provided payment for his participation in the study; he has not been compensated for contributing to this press release.

SOURCE Janssen Pharmaceutical Companies of Johnson & Johnson

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