RARITAN, N.J., Nov. 6, 2015 /PRNewswire/ -- Janssen Pharmaceuticals, Inc., and its development partner, Bayer HealthCare, today announced that 17 data presentations, generated from the EXPLORER cardiovascular research program for XARELTO® (rivaroxaban), will be presented at this year's American Heart Association Scientific Sessions 2015. Notably, the performance of XARELTO® in core areas that impact patient safety will be highlighted at the congress, including patients with renal disease and real-world persistence rates compared to selected oral anticoagulants. Additionally, full results from the second part of the Phase 3 ANNEXA-R (Andexanet Alfa a Novel Antidote to the Anticoagulant Effects of FXa Inhibitors – Rivaroxaban) study will be presented during a late-breaking clinical trial session.
"We look forward to sharing new research from our global EXPLORER cardiovascular research program, including important data on the safety and efficacy of XARELTO® in non-valvular atrial fibrillation patients with renal disease and insights from real-world observational studies on the safety of our medicine," said Hayes Dansky, M.D., Therapeutic Area Leader, Cardiovascular, Janssen. "XARELTO® continues to lead the way with the most published data in the Factor Xa class examining critical aspects of treatment in the real-world setting, including safety, efficacy and adherence. Our work continues to equip physicians with important data that can help inform the care of their patients."
The EXPLORER program evaluates the use of XARELTO® in a broad range of cardiovascular conditions, addressing critical medical needs and generating important clinical evidence on the real-world safety performance of the medicine. By the time of its completion, more than 275,000 patients will have participated in the XARELTO® EXPLORER clinical development program, which includes ongoing and completed studies, independent registries and non-interventional studies.
EXPLORER is a collaborative research effort with Bayer HealthCare and is a blend of completed and ongoing studies that includes six additional indication-seeking programs. EXPLORER continues to assess the safety and efficacy of XARELTO® in high-risk patient populations, such as those with chronic heart failure and coronary artery disease, peripheral artery disease, acute coronary syndrome, embolic stroke of undetermined source, active cancer or who are medically ill. Three of the studies look at different non-valvular atrial fibrillation (NVAF) populations:
A listing of the data presentations is included below:
Late-Breaking Clinical Trial
(LBCT 04) ANNEXA-R Part 2: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial Demonstrating Sustained Reversal of Rivaroxaban-Induced Anticoagulation in Older Subjects by Andexanet Alfa, a Universal Antidote for Factor XA Inhibitors. Oral presentation: Wednesday, Nov. 11, 11:21-11:30 a.m. ET. Location: Chapin Theater.
Phase 3 Clinical Trial Sub-Analyses
(316) On-Treatment Outcomes in Patients with Worsening Renal Function with Rivaroxaban Compared to Warfarin: Insights from ROCKET AF. Oral presentation: Monday, Nov. 9, 2:00-2:15 p.m. ET. Location: W312C.
(S 4081) Efficacy and Safety of Rivaroxaban versus Warfarin in Patients Taking Non-dihydropyridine Calcium Channel Blockers: Results from the ROCKET AF Trial. Poster presentation: Sunday, Nov. 8, 9:00-10:15 a.m. ET. Location: A2, Clinical Science.
Real-World Data Analyses
(M 2074) Incidence and Characteristics of Major Bleeding Among Rivaroxaban Users with Renal Disease and Non-Valvular Atrial Fibrillation. Poster presentation: Monday, Nov. 9, 9:00-10:15 a.m. ET. Location: A2, Population Science.
(M 2077) Treatment Persistence and Discontinuation with Rivaroxaban, Dabigatran and Warfarin for Stroke Prevention in Patients with Non-Valvular Atrial Fibrillation. Poster presentation: Monday, Nov. 9, 9:00-10:15 a.m. ET. Location: A2, Population Science.
(M 2155) Adherence to Non-VKA Oral Anticoagulant Medications Based on the Pharmacy Quality Alliance Measure. Poster presentation: Monday, Nov. 9, 2:00-3:15 p.m. ET. Location: A2, Population Science.
(QCOR09) Evaluation of U.S. Prescription Patterns: Are Treatment Guidelines for Cancer-associated Venous Thromboembolism (VTE) Followed? Poster presentation: Monday, Nov. 9, 9:30-11:00 a.m. ET. Location: A2, Best of AHA Specialty Conferences.
(S 2123) Real-Life Evidence of Stroke Prevention in Patients with Atrial Fibrillation: The RELIEF Study. Poster presentation: Sunday, Nov. 8, 2:00-3:15 p.m. ET. Location: A2, Population Science.
(840) Risk Factors for Major Bleeding Events in Rivaroxaban Users with Atrial Fibrillation: A Nested Case-Control Study. Oral presentation: Tuesday, Nov. 10, 9:30-9:40 a.m. ET. Location: A2, Population Science Theater.
Registry Data
(S 4088) Frequency and Management of Major Bleeding in Atrial Fibrillation Patients Treated with Warfarin and Non-Vitamin K Oral Anticoagulants in Community Practice: Results from the ORBIT-AF II Registry. Poster presentation: Sunday, Nov. 8, 9:00-10:15 a.m. ET. Location: A2, Clinical Science.
(M 4058) Comparative Performance of the R2CHADS2, CHADS2, and CHA2DS2–VASc Scores in Atrial Fibrillation. Poster presentation: Monday, Nov. 9, 9:00-10:15 a.m. ET. Location: A2, Clinical Science.
(M 2076) Therapeutic Strategies Following Major Bleeding in Atrial Fibrillation: Findings from ORBIT-AF. Poster presentation: Monday, Nov. 9, 9:00-10:15 a.m. ET. Location: A2, Population Science.
Clinical Characteristics and Treatment Patterns of Medicaid Patients with Atrial Fibrillation: Insights from the ORBIT-AF I Registry. Oral presentation: Tuesday, Nov. 10, 11:15-11:30 a.m. ET. Location: W414CD.
(T 4046) Rhythm Control Versus Rate Control and Clinical Outcomes in Patients with Atrial Fibrillation: Results from ORBIT-AF. Poster presentation: Tuesday, Nov. 10, 9:00-10:15 a.m. ET. Location: A2, Clinical Science.
(T 4051) Patterns of Discontinuation for Non-Vitamin K Oral Anticoagulants in Atrial Fibrillation: Results from the ORBIT-AF II Registry. Poster presentation: Tuesday, Nov. 10, 9:00-10:15 a.m. ET. Location: A2, Clinical Science.
(T 4266) Factors Associated with Quality of Life in Atrial Fibrillation: Results from the ORBIT-AF Registry. Poster presentation: Tuesday, Nov. 10, 2:00-3:15 p.m. ET. Location: A2, Clinical Science.
Association of Body Mass Index with Outcomes in Patients with Atrial Fibrillation: Results from the ORBIT-AF Registry. Poster presentation: Tuesday, Nov. 10, 2:00-3:30 p.m. ET. Location: Valencia Ballroom (W415AB).
Persistence on Dabigatran vs. Warfarin in Patients with Atrial Fibrillation: Results from the ORBIT-AF Registry. Poster presentation: Tuesday, Nov. 10, 2:00-3:30 p.m. Location: Valencia Ballroom (W415AB).
For more information, including a complete list of abstract titles, visit the American Heart Association Scientific Sessions website at http://www.abstractsonline.com/pp8/#!/3795/.
About XARELTO® (rivaroxaban)
XARELTO® works by blocking the blood clotting Factor Xa. XARELTO® does not require routine blood monitoring. XARELTO® has a broad indication profile and is approved for six indications that include:
IMPORTANT SAFETY INFORMATION:
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT XARELTO®?
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.
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:
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:
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 patients with artificial heart valves.
WHO SHOULD NOT TAKE XARELTO®?
Do not take XARELTO® if you:
WHAT SHOULD I TELL MY DOCTOR BEFORE OR WHILE TAKING XARELTO®?
Before taking XARELTO®, tell your doctor 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 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:
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.
If you take XARELTO® for:
WHAT ARE THE POSSIBLE SIDE EFFECTS OF XARELTO®?
Please see "What is the most important information I should know about XARELTO®?" above.
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.
Janssen and Bayer HealthCare together are developing rivaroxaban.
For more information about XARELTO®, visit www.xarelto-us.com. The XARELTO® CarePath™ Support Program is a resource designed for healthcare providers, patients and caregivers. Visit www.xareltocarepath.com or call 1-888-XARELTO to learn more about the XARELTO® CarePath™ resources focused on access, education and adherence.
About Janssen
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical 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 Pharmaceuticals, Inc. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit www.JanssenPharmaceuticalsInc.com for more information.
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. 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 Biotech, Inc., Janssen Research & Development, LLC and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in new product development, including the uncertainty of clinical success and of obtaining regulatory approvals; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. 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 28, 2014, 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 or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
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