RARITAN, N.J., March 21, 2016 /PRNewswire/ -- Janssen Pharmaceuticals, Inc., and its development partner, Bayer, today announced that 13 data presentations will be presented at the American College of Cardiology's 65th Annual Scientific Session (ACC.16), including real-world findings confirming the safety of XARELTO® (rivaroxaban) in a high-risk group of patients with non-valvular atrial fibrillation (NVAF) and concomitant diabetes. This real-world research complements the XARELTO® clinical trials by providing important insights to physicians on how the medicine is performing in patients seen in everyday practice.
Data from these 13 abstracts are generated from the XARELTO® EXPLORER program, which has evaluated XARELTO® in more than 91,000 patients in real-world settings to date. Other topic areas that will be presented include adherence, hospitalization length of stay and hospital costs, including outcomes in patients undergoing treatment for venous thromboembolism (VTE).
Nearly six million Americans are living with atrial fibrillation, and based on data of Medicare beneficiaries, an estimated 34 percent of people with NVAF also have diabetes. The risk of stroke is 1.5 times higher in people with NVAF and concomitant diabetes than in those without diabetes. Adhering to dietary guidelines is important for people with diabetes, and warfarin, an older anticoagulant often prescribed to NVAF patients, carries dietary restrictions, making treatment challenging for people living with both conditions. XARELTO®, given once daily with no dietary restrictions or blood monitoring required, could be a proven treatment option for NVAF patients with diabetes.
"It is critically important that we continue to assess the performance of once-daily XARELTO® in high-risk NVAF patients seen in everyday practice, and at the ACC Annual Scientific Session we will show how the medicine is performing in patients with concomitant diabetes," said Paul Burton, MD, PhD, Vice President, Medical Affairs, Janssen. "Additionally, our research continues to evaluate the value that XARELTO® offers healthcare systems beyond the medicine's best-in-class access and affordability in the U.S., and we look forward to sharing further data on this important topic."
Below is a listing of the data presentations for XARELTO® at ACC.16:
High-Risk Populations
Value/Adherence
Registry
Measurement
For more information, including a complete list of abstract titles, visit the official website for ACC.16 here.
About the EXPLORER Clinical Development Program
A collaborative research effort with Bayer, EXPLORER evaluates the use of XARELTO® in a broad range of cardiovascular conditions. The focus of EXPLORER is two-fold: to research the potential role of XARELTO® in addressing additional critical needs; and, to generate important clinical evidence on the performance of XARELTO® in the real world. EXPLORER includes six additional indication-seeking trials beyond the currently approved six indications in the U.S. 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.
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®?
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 together are developing rivaroxaban.
For more information about XARELTO®, visit www.xarelto.com.
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 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 Pharmaceuticals, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges inherent in new product research and development, including uncertainty of clinical success and 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 January 3, 2016, 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.
Media Contacts:
Kristina Chang
Tel: (908) 927-2416
Mobile: (201) 213-4115
kchang12@its.jnj.com
Christina Chan
Tel: (908) 927-5769
Mobile: (908) 635-2406
cchan20@its.jnj.com
Investor Relations Contacts:
Johnson & Johnson
Louise Mehrotra
Tel: (732) 524-6491
Johnson & Johnson
Lesley Fishman
Tel: (732) 524-3922
Logo - http://photos.prnewswire.com/prnh/20151106/284644LOGO
SOURCE Janssen Pharmaceuticals, Inc.