RARITAN, N.J. (August 29, 2014) – Janssen Research & Development, LLC (Janssen) and its development partner, Bayer HealthCare, announced today the expansion of the EXPLORER global cardiovascular research program for XARELTO® (rivaroxaban) to include additional high-risk patient populations. New trials will investigate rivaroxaban, the most studied Factor Xa inhibitor, for the treatment of acute coronary syndrome (ACS), embolic stroke of undetermined source (ESUS) and peripheral artery disease (PAD). If this research is successful, Janssen may seek FDA approval of XARELTO® for these indications.
“Since March of 2013, through our ongoing partnership with Bayer, we have announced 11 new trials as part of our EXPLORER clinical trial program, with more indication-seeking trials underway than any other oral anticoagulant,” said Anne Hermanowski Vosatka, M.D., Ph.D, FACC, Vice President and Compound Development Team Leader for XARELTO®, Janssen. “These new studies will help us to uncover the full potential of this medicine in making a difference for patients with critical medical needs.”
The new trials initiated by Janssen and its development partner, Bayer HealthCare, are:
- GEMINI 1 & 2 ACS, a global indication-seeking clinical program, designed to evaluate rivaroxaban in patients who suffer from acute coronary syndrome (ACS). The program will launch with GEMINI 1 ACS, to investigate the benefits of the dual pathway strategy of anticoagulation with rivaroxaban in combination with a single antiplatelet agent for long-term secondary prevention of additional cardiovascular events in patients with ACS. The study will include 2,000 to 3,000 patients in more than 10 countries. If successful, the Phase 2 study will be followed by GEMINI 2 ACS, a global Phase 3 study. The GEMINI ACS program builds off the global 19,000 patient ATLAS ACS 2-TIMI 51 trial, which showed treatment with XARELTO® resulted in reductions in important cardiovascular events.
ACS is a complication of coronary heart disease which is the leading cause of death in the United States. ACS is typically associated with the disruption of an atherosclerotic plaque and subsequent formation of a blood clot that can cause a sudden reduction in blood flow to the heart. Reduced blood flow to the heart can result in a heart attack or unstable angina, a condition signifying that a heart attack may soon occur. Each year more than 1.1 million Americans are discharged from the hospital with a primary or secondary diagnosis of ACS.
- NAVIGATE ESUS, a global Phase 3 indication-seeking study, designed to evaluate rivaroxaban in patients with embolic stroke of undetermined source (ESUS). The study will include at least 7,000 patients in over 25 countries.
Each year, more than 690,000 people in the United States are estimated to suffer an ischemic stroke, a condition where the blood flow to the brain is blocked by a clot. In approximately 25 percent of these patients, the embolic source causing the stroke is unknown, and there is limited knowledge available to guide treatment decisions for these patients.
- VOYAGER PAD, a global Phase 3 indication-seeking study, designed to evaluate rivaroxaban in patients with peripheral artery disease (PAD) undergoing peripheral artery interventions. The study will include at least 5,000 patients in more than 20 countries.
PAD is estimated to affect more than eight million Americans age 40 and above, with prevalence increasing with age. PAD occurs when the build-up of plaque, or atherosclerosis, narrows or blocks vessels that transport blood from the heart to the limbs. Patients with PAD are at increased risk of heart attack and stroke.
About the EXPLORER Global Cardiovascular Research Program
EXPLORER is an integral part of the extensive clinical development program for rivaroxaban, evaluating its use in a broad range of cardiovascular conditions. The global clinical development program for rivaroxaban, including EXPLORER, encompasses 17 Phase 3 clinical trials, 10 of which are completed. By the time of its completion, more than 275,000 patients will have participated in the rivaroxaban clinical development program, including completed and ongoing clinical trials, independent registries and non-interventional studies. More than 151,000 of those patients have been or will be part of controlled, randomized clinical trials.
Additional studies within the EXPLORER program include:
- X-VeRT, the first prospective exploratory trial comparing the efficacy and safety of a Factor Xa inhibitor, rivaroxaban, once-daily, to dose-adjusted vitamin K antagonist (VKA) treatment, such as warfarin, in patients with non-valvular atrial fibrillation (NVAF) undergoing cardioversion. Cardioversion is a common medical procedure that converts an abnormally fast heart rate to a normal rhythm using electricity or antiarrhythmic medications. The findings of the X-VeRT trial will be presented in a Hot Line Session at ESC Congress 2014 in Barcelona, Spain, on September 2, 2014.
- EINSTEIN CHOICE, an ongoing study of long-term reduction in the risk of recurrent deep vein thrombosis (DVT) or pulmonary embolism (PE) comparing standard dose rivaroxaban and reduced dose rivaroxaban to aspirin.
- EINSTEIN JUNIOR, an ongoing study examining rivaroxaban for the treatment and secondary prevention of DVT and/or PE in pediatric populations.
- MARINER, an ongoing study examining rivaroxaban in reducing the risk of recurrent DVT and PE in acutely medically ill patients post hospital discharge.
- COMMANDER-HF, an ongoing study examining rivaroxaban in reducing the risk of major adverse cardiac events (MACE) in patients with chronic heart failure and significant coronary artery disease.
- COMPASS, an ongoing study examining rivaroxaban in reducing the risk of MACE in patients with coronary or peripheral artery disease.
- VENTURE-AF, on ongoing study of the safety of rivaroxaban and vitamin K antagonist (VKA) in patients with NVAF undergoing catheter ablation.
- PIONEER AF-PCI, an ongoing study evaluating rivaroxaban in patients with NVAF after percutaneous coronary intervention with stent placement.
About XARELTO® (rivaroxaban):
Nine million patients have received XARELTO® worldwide, and more than eight million prescriptions have been written for XARELTO® in the U.S. XARELTO® is broadly reimbursed with 96 percent of patients on Medicare Part D and 92 percent of commercial patients covered at the lowest branded co-pay. XARELTO® has a broad indication profile and is approved for six indications:
- To reduce the risk of strokes and blood clots in patients with atrial fibrillation not caused by a heart valve problem. For patients currently well managed on warfarin, there is limited information on how XARELTO® and warfarin compare in reducing the risk of stroke.
- To treat patients with deep vein thrombosis (DVT).
- To treat patients with pulmonary embolism (PE).
- To reduce the risk of recurrence of DVT or PE following an initial six-month treatment for acute venous thromboembolism.
- To reduce the risk of blood clots in the legs and lungs of patients who have just had knee replacement surgery.
- To reduce the risk of blood clots in the legs and lungs of patients who have just had hip replacement surgery.
WHAT IS XARELTO®?
XARELTO® is a prescription medicine used to reduce the risk of stroke and blood clots in people with atrial fibrillation, not caused by a heart valve problem. For patients currently well managed on warfarin, there is limited information on how XARELTO® and warfarin compare in reducing the risk of stroke.
XARELTO® is also a prescription medicine used to treat deep vein thrombosis and pulmonary embolism, and to help reduce the risk of these conditions occurring again.
XARELTO® is also a prescription medicine used to reduce the risk of forming a blood clot in the legs and lungs of people who have just had knee or hip replacement surgery.
IMPORTANT SAFETY INFORMATION
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT XARELTO®?
• For people taking XARELTO® for atrial fibrillation:
People with atrial fibrillation (an irregular heart beat) 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.
• XARELTO® can cause bleeding, which can be serious, and rarely may lead to death. This is because XARELTO® is a blood thinner medicine that reduces blood clotting. While you take XARELTO® you are likely to bruise more easily and it may take longer for bleeding to stop.
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
• Non-steroidal anti-inflammatory drugs (NSAIDs)
• Warfarin sodium (Coumadin®, Jantoven®)
• Any medicine that contains heparin
• Clopidogrel (Plavix®)
• 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 that 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), loss of control of the bowels or bladder (incontinence).
XARELTO® is not for patients with artificial heart valves.
WHO SHOULD NOT TAKE XARELTO®?
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®.
WHAT SHOULD I TELL MY DOCTOR BEFORE OR WHILE TAKING XARELTO®?
Before taking XARELTO®, tell your doctor if you:
• Have ever had bleeding problems
• Have liver or kidney problems
- Have any other medical condition
• 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 while taking XARELTO®. If you take XARELTO® during pregnancy, tell your doctor right away if you have bleeding or symptoms of blood loss.
• Are breastfeeding or plan to breastfeed. It is not known if XARELTO® passes into your breast milk. You and your doctor should decide if you will take XARELTO® or breastfeed.
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 nonprescription medicines, vitamins, and herbal supplements. Some of your other medicines may affect the way XARELTO® works. Certain medicines may increase your risk of bleeding. See “What is the most important information I should know about XARELTO®?”
Especially tell your doctor if you take:
• Ketoconazole (Nizoral®)
• Itraconazole (Onmel™, Sporanox®)
• Ritonavir (Norvir®)
• Lopinavir/ritonavir (Kaletra®)
• Indinavir (Crixivan®)
• Carbamazepine (Carbatrol®, Equetro®, Tegretol®, Tegretol®-XR, Teril™, Epitol®)
• Phenytoin (Dilantin-125®, Dilantin®)
• Phenobarbital (Solfoton™)
• Rifampin (Rifater®, Rifamate®, Rimactane®, Rifadin®)
• St. John’s wort (Hypericum perforatum)
Ask your doctor if you are not sure if your medicine is one listed above. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
HOW SHOULD I TAKE XARELTO®?
Take XARELTO® exactly as prescribed by your doctor.
Do not change your dose or stop taking XARELTO® unless your doctor tells you to.
- Your doctor will tell you how much XARELTO®to take and when to take it.
- Your doctor may change your dose if needed.
If you take XARELTO® for:
- Atrial Fibrillation: Take XARELTO® 1 time a day with your evening meal.
If you miss a dose of XARELTO®, take it as soon as you remember on the same day. Take your next dose at your regularly scheduled time.
- Blood clots in the veins of your legs or lungs:
- Take XARELTO® once or twice a day as prescribed by your doctor.
- Take XARELTO® with food at the same time each day.
- If you miss a dose of XARELTO®:
- and take XARELTO® 2 times a day: Take XARELTO® as soon as you remember on the same day. You may take 2 doses at the same time to make up for the missed dose. Take your next dose at your regularly scheduled time.
- and take XARELTO® 1 time a day: Take XARELTO® as soon as you remember on the same day. Take your next dose at your regularly scheduled time.
- Hip or knee replacement surgery: Take XARELTO® 1 time a day with or without food. If you miss a dose of XARELTO®, take it as soon as you remember on the same day. Take your next dose at your regularly scheduled time.
- If you have difficulty swallowing the tablet whole, talk to your doctor about other ways to take XARELTO®.
- Your doctor will decide how long you should take XARELTO®. Do not stop taking XARELTO®without talking to your doctor first.
- Your doctor may stop XARELTO® for a short time before any surgery, medical or dental procedure. Your doctor will tell you when to start taking XARELTO® again after your surgery or procedure.
- Do not run out of XARELTO®. Refill your prescription for XARELTO® before you run out. When leaving the hospital following a hip or knee replacement, be sure that you have XARELTO® available to avoid missing any doses.
- If you take too much XARELTO®, go to the nearest hospital emergency room or call your doctor right away.
WHAT ARE THE POSSIBLE SIDE EFFECTS OF XARELTO®?
Please see “What is the most important information I should know about XARELTO®?”
Tell your doctor if you have any side effect that bothers you or that does not go away.
Call your doctor for medical advice about side effects. You are also encouraged to report side effects to the FDA: visit http://www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Janssen Pharmaceuticals, Inc., at 1-800-JANSSEN (1-800-526-7736).
Please click here for full Prescribing Information, including Boxed Warnings, and Medication Guide.
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At Janssen, we are dedicated to addressing and solving some of the most important unmet needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world. Janssen Research & Development, LLC and Janssen Pharmaceuticals, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit http://www.janssenrnd.com for more information.
(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995, including regarding product development. 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 and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges inherent in new product development, including obtaining regulatory approvals; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; changes to governmental laws and regulations and domestic and foreign health care reforms; general industry conditions, including trends toward health care cost containment; and increased scrutiny of the health care industry by government agencies. A further list and description 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 December 29, 2013, including in Exhibit 99 thereto, 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 undertake to update any forward-looking statements as a result of new information or future events or developments.)
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