05/16/2021 | Press release | Distributed by Public on 05/16/2021 06:18
RARITAN, N.J., May 16, 2021 - The Janssen Pharmaceutical Companies of Johnson & Johnson today presented new data from the Phase 3 VOYAGER PAD study which showed XARELTO® (rivaroxaban) (2.5 mg twice daily) in combination with aspirin (100 mg once daily) consistently reduced severe vascular events in patients with peripheral artery disease (PAD) after lower-extremity revascularization (LER) compared to aspirin alone regardless of whether it was the first, second, third, or subsequent event. The primary results of VOYAGER PAD showed that XARELTO® plus aspirin reduced first events by 15 percent among patients with PAD after LER. This analysis showed a very high burden of subsequent events and a consistent 14 percent reduction in both primary endpoint events and total vascular events over a median of 2.5 years. These data were presented as a late-breaking presentation during the virtual American College of Cardiology's 70th Annual Scientific Session (ACC.21) and simultaneously published in the Journal of the American College of Cardiology.
PAD is a chronic circulatory condition which causes blood vessels to narrow, thereby reducing blood flow to the limbs, most often the legs.1 An estimated 20 million Americans are living with PAD, but only 8.5 million are currently diagnosed.2 While usually starting as asymptomatic, PAD symptoms can progress to severe and require revascularization to avoid amputation.
'Even years after revascularization, patients with PAD continue to have a markedly high-risk for future thrombotic events due to excessive thrombin generation and platelet aggregation,' said Marc P. Bonaca*, M.D., Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado. 'This analysis from VOYAGER PAD looked beyond the first event and found subsequent thrombotic event reduction with rivaroxaban plus aspirin, underscoring the importance of long-term prevention in these high-risk patients.'
CLICK TO TWEET: Late-breaking data at #ACC21 offer insights on long-term prevention of future thrombotic events in patients with #PAD after lower-extremity revascularization. Full @JanssenUS press release here: https://bit.ly/33sm1yt
In addition to evaluating the time to first event, this sub-analysis from VOYAGER PAD also evaluated thrombotic events that occurred after the first event. Specifically, it showed XARELTO® plus aspirin significantly reduced total primary endpoint events (acute limb ischemia, major amputation for vascular causes, non-fatal myocardial infarction, non-fatal ischemic stroke, or death from vascular causes) compared to aspirin alone (Hazard Ratio (HR)=0.86, 95% Confidence Internal (CI) 0.75 to 0.98; p=0.02). The XARELTO® plus aspirin regimen also significantly reduced total vascular events (all primary endpoints plus subsequent peripheral revascularizations of both index and contralateral leg and venous thromboembolic events) compared to aspirin alone (HR 0.86, 95% CI 0.79 to 0.95; p=0.003). No significant increase in Thrombolysis in Myocardial Infarction (TIMI) major bleeding was observed in the VOYAGER PAD study in patients treated with XARELTO® plus aspirin compared to aspirin alone (2.65% vs. 1.87% respectively; HR=1.43, 95% CI, 0.97-2.10; p=0.07).
'The VOYAGER PAD trial is the first and only study of antithrombotic therapy in the past 20 years to demonstrate a significant benefit in patients with peripheral artery disease after lower-extremity revascularization,' said James List, M.D., Ph.D., Global Therapeutic Area Head, Cardiovascular & Metabolism, Janssen Research & Development, LLC. 'With these new data, we now have a full picture of evidence demonstrating the potential of XARELTO® in treating patients through various stages of peripheral artery disease - chronic, symptomatic, those requiring revascularization and beyond.'
On October 26, 2020, Janssen announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration to expand the use of XARELTO® in patients with PAD to include reducing the risk of major thrombotic vascular events, such as heart attack and amputation, in symptomatic patients after recent LER. XARELTO® is currently approved in combination with aspirin to reduce the risk of major cardiovascular (CV) events (CV death, myocardial infarction and stroke) in patients with chronic coronary artery disease (CAD) or PAD.
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 administered at the treating physician's discretion. Patients were followed for a median of 28 months.
The primary efficacy endpoint was a composite of major adverse limb and cardiovascular (CV) events, including acute limb ischemia, major amputation for vascular causes, heart attack (myocardial infarction), ischemic stroke, or death from CV causes. Additional prespecified categories of vascular events included subsequent peripheral revascularizations of both index and contralateral leg and venous thromboembolic events. The principal safety endpoint was major bleeding according to the TIMI classification.
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 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 back pain, tingling, numbness, muscle weakness (especially in your legs and feet), or loss of control of the bowels or bladder (incontinence).
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:
Before taking XARELTO®, tell your doctor about all your medical conditions, including if you:
Tell all of your doctors and dentists that you 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 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:
WHAT ARE THE POSSIBLE SIDE EFFECTS OF XARELTO®?
XARELTO® may cause serious side effects:
The most common side effect of XARELTO® was bleeding.
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).
Trademarks are those of their respective owners.
Janssen and Bayer together are developing rivaroxaban. For more information about XARELTO®, visit www.xarelto.com.
Cautions Concerning Forward-Looking Statements
This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding 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 Research & Development, 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 3, 2021, including in the sections captioned 'Cautionary Note Regarding Forward-Looking Statements' and 'Item 1A. Risk Factors,' and in the company's most recently filed Quarterly Report on Form 10-Q, and the company's subsequent 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.
1. American Heart Association. About Peripheral Artery Disease (PAD). Retrieved April 29, 2021 from https://www.heart.org/en/health-topics/peripheral-artery-disease/about-peripheral-artery-disease-pad
2. American Heart Association. Peripheral Artery Disease (PAD) Resources For Patients and Providers. Retrieved April 29, 2021 from https://www.heart.org/en/health-topics/peripheral-artery-disease/pad-resources
*CPC Clinical Research was provided a grant for their participation in the Phase 3 VOYAGER PAD clinical trial.