Janssen Highlights Continued Commitment to Cardiovascular & Metabolic Healthcare Solutions with Late-Breaking Data at the First Fully Virtual American College of Cardiology Scientific Session

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that it will unveil late-breaking data from its leading cardiovascular and metabolism portfolio during the virtual American College of Cardiology's 69th Annual Scientific Session together with the World Congress of Cardiology (ACC.20/WCC) on March 28-30, 2020. Notably, four late-breaking abstracts for XARELTO® (rivaroxaban) will be presented, including data from the Phase 3 VOYAGER PAD study in patients with symptomatic peripheral artery disease (PAD) after lower-extremity revascularization.

"The depth of our research at ACC this year is a testament to how our medicines help improve care for people living with cardiovascular diseases, type 2 diabetes and diabetic kidney disease," said James List, M.D., Ph.D., Global Therapeutic Area Head, Cardiovascular & Metabolism, Janssen Research & Development, LLC. "We look forward to sharing the latest evidence from our portfolio that we believe will continue to help shape clinical practice."

Janssen's cardiovascular and metabolism franchise includes XARELTO®, a direct oral anticoagulant (DOAC) with eight indications – the most of any DOAC in the class – and INVOKANA® (canagliflozin), the only type 2 diabetes (T2D) medicine proven to slow the progression of diabetic nephropathy, also known as diabetic kidney disease (DKD), and reduce the risk of hospitalization for heart failure in patients with T2D and DKD with albuminuria >300 mg/day.

Highlights from the Janssen cardiovascular and metabolism portfolio to be presented during ACC.20/WCC include:

Cardiovascular:

• VOYAGER PAD (main results and subgroup analysis): The first Phase 3 randomized study to evaluate a dual pathway approach with XARELTO® (2.5 mg twice daily) plus aspirin (100 mg once daily) for reducing the risk of major adverse limb and cardiovascular (CV) events in patients with symptomatic PAD undergoing lower-extremity revascularization (a procedure to improve blood flow in the legs). A prespecified subgroup analysis that evaluated outcomes in patients who received clopidogrel will also be presented.
• COMPASS (diabetes analysis): A prespecified subgroup analysis from the COMPASS study evaluated the benefit of XARELTO® (2.5 mg twice daily) plus aspirin (100 mg once daily) in patients with stable coronary artery disease (CAD) and/or PAD with T2D versus those without T2D. Primary results from COMPASS showed that the dual pathway approach of XARELTO® plus aspirin significantly reduced the risk of major CV events in patients with chronic PAD and/or CAD compared to aspirin alone.
• PRONOMOS: This randomized study evaluated the use of XARELTO® in preventing venous thromboembolism (VTE), or blood clots, in patients after undergoing non-major orthopedic surgery.

Metabolism:

• CREDENCE: Four new analyses from the CREDENCE study in T2D and DKD examined the effect of INVOKANA® on specific patient subgroups. Primary endpoint results from CREDENCE showed INVOKANA® significantly reduced the composite risk of end-stage kidney disease (ESKD), doubling of serum creatinine and renal or CV death in patients with DKD and T2D, and also reduced the risk of hospitalization for heart failure.

Following is a full list of abstracts for XARELTO® and INVOKANA® to be presented during ACC.20/WCC:

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.
  
  You may have a higher risk of bleeding if you take XARELTO® and take other medicines that increase your risk of bleeding, including:
  • Aspirin or aspirin-containing products
  • Long-term (chronic) use of non-steroidal anti-inflammatory drugs (NSAIDs)
  • Warfarin sodium (Coumadin®, Jantoven®)
  • Any medicine that contains heparin
  • Clopidogrel (Plavix®)
  • Selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs)
  • Other medicines to prevent or treat blood clots

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:

• • Unexpected bleeding or bleeding that lasts a long time, such as:
    • Nosebleeds that happen often
    • Unusual bleeding from gums
    • Menstrual bleeding that is heavier than normal, or vaginal bleeding
  • Bleeding that is severe or you cannot control
  • Red, pink, or brown urine
  • Bright red or black stools (looks like tar)
  • Cough up blood or blood clots
  • Vomit blood or your vomit looks like "coffee grounds"
  • Headaches, feeling dizzy or weak
  • Pain, swelling, or new drainage at wound sites
• Spinal or epidural blood clots (hematoma). People who take a blood thinner medicine (anticoagulant) like XARELTO®, and have medicine injected into their spinal and epidural area, or have a spinal puncture, have a risk of forming a blood clot that can cause long-term or permanent loss of the ability to move (paralysis). Your risk of developing a spinal or epidural blood clot is higher if:
  • A thin tube called an epidural catheter is placed in your back to give you certain medicine
  • You take NSAIDs or a medicine to prevent blood from clotting
  • You have a history of difficult or repeated epidural or spinal punctures
  • You have a history of problems with your spine or have had surgery on your spine

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:

• Currently have certain types of abnormal bleeding. Talk to your doctor before taking XARELTO® if you currently have unusual bleeding.
• Are allergic to rivaroxaban or any of the ingredients of XARELTO®.

Before taking XARELTO®, tell your doctor about all your medical conditions, including if you:

• Have ever had bleeding problems
• Have liver or kidney problems
• Have antiphospholipid syndrome (APS)
• Are pregnant or plan to become pregnant. It is not known if XARELTO® will harm your unborn baby.
  • Tell your doctor right away if you become pregnant during treatment with XARELTO®. Taking XARELTO® while you are pregnant may increase the risk of bleeding in you or in your unborn baby.
  • If you take XARELTO® during pregnancy, tell your doctor right away if you have any signs or symptoms of bleeding or blood loss. See "What is the most important information I should know about XARELTO®?" for signs and symptoms of bleeding.
• Are breastfeeding or plan to breastfeed. XARELTO® may pass into your breast milk. Talk to your doctor about the best way to feed your baby during treatment with XARELTO®.