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Classified in: Health
Subject: FDA

U.S. FDA Approves XARELTO® (rivaroxaban) to Help Prevent Blood Clots in Acutely Ill Medical Patients


RARITAN, N.J., Oct. 14, 2019 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved XARELTO® (rivaroxaban) for the prevention of venous thromboembolism (VTE), or blood clots, in hospitalized acutely ill medical patients at risk for thromboembolic complications who are not at high risk of bleeding. With the approval of this new indication, XARELTO® can be initiated for these patients during hospitalization and continued after discharge for a total recommended duration of 31 to 39 days. To date, the FDA has granted XARELTO® eight indications ? the most of any direct oral anticoagulant (DOAC) ? six of which are specifically for the treatment, prevention and reduction in the risk of recurrence of VTE across a wide range of patient populations.

Janssen Pharmaceuticals Logo (PRNewsfoto/Janssen Pharmaceutical Companies)

Click to Tweet: New oral treatment option now approved to help prevent #bloodclots #VTE in adults hospitalized for an acute medical illness, providing an alternative to injectable anticoagulants, which have long been the standard of care https://ctt.ec/UOp3r+

"With this new approval, XARELTO® as an oral-only option now has the potential to change how acutely ill medical patients are managed for the prevention of blood clots, both in the hospital and for an extended period after discharge," said Alex C. Spyropoulos, M.D., Professor of Medicine, The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Northwell Health at Lenox Hill Hospital, New York, NY.1 "The Phase 3 clinical studies in this high-risk patient group show us that XARELTO® at the 10mg dose is an effective and safe option to help prevent blood clots."

More than seven million Americans are hospitalized each year with an acute medical illness, which is a broad term used to describe serious, yet common, medical conditions.i These patients are at increased risk of blood clots for up to three months after hospital discharge, with 80 percent of events happening within the first six weeks.ii,iii In response to the burden of VTE in hospitalized patients, the Surgeon General issued a Call to Action in 2008 for key stakeholders to build a coordinated plan that could lead to a reduction in VTE across the U.S.iv However, a recent study found that in-hospital VTE rates continue to rise and more work is needed to reduce the burden of VTE especially among those at lower risk.v

Guidelines currently recommend that acutely ill medical patients at risk of VTE receive anticoagulants, typically injectable agents, in the hospital to protect them from blood clots, but advise against routine anticoagulant use after leaving the hospital.vi,vii Research shows that many patients refuse treatment with injectable anticoagulants out of fear, discomfort, anxiety or inconvenience.viii

"Preventing blood clots is a critical priority for physicians treating patients with acute medical illnesses, which is why Janssen is pleased that the FDA approved the use of XARELTO® to address this often fatal, yet preventable condition," said James List, M.D., Ph.D., Global Therapeutic Area Head, Cardiovascular & Metabolism, Janssen Research & Development, LLC. "Rather than facing daily injections with older anticoagulants, patients now have a new oral treatment option that will help prevent blood clots, both in the hospital and after hospital discharge."

About the Phase 3 Clinical Program
More than 20,000 patients with acute medical illnesses were evaluated in the Phase 3 clinical programix,x,which includes the MAGELLAN and MARINER studies. Published in 2013, MAGELLAN evaluated the use of XARELTO® in preventing VTE in hospitalized patients with an acute medical illness and restricted mobility, starting with their hospital stay and continuing through post-hospital discharge. The study met its two co-primary efficacy endpoints, with XARELTO® demonstrating non-inferiority to enoxaparin, a low-molecular-weight heparin (LMWH), in short-term use (10 ± 4 days) and superiority in long-term use (35 ± 4 days) compared to short-term use of enoxaparin followed by placebo. The combined rates of major and non-major clinically relevant bleeding were higher in the XARELTO® group.

An important post-hoc analysis from MAGELLAN found that, by applying five additional exclusionary criteria to remove patients at high risk for bleeding due to active gastroduodenal ulcer, recent bleeding, active cancer, history of severe bronchiectasis or pulmonary cavitation, or dual antiplatelet therapy at baseline, researchers established a favorable benefit-risk profile for VTE prevention with XARELTO®.

Additionally, building on the foundation from MAGELLAN, the Phase 3 MARINER trial was conducted in a similar population of acutely ill medical patients. Published in 2018, MARINER evaluated XARELTO® for the prevention of VTE and VTE-related death following hospital discharge compared to placebo. While XARELTO® did not reduce the composite endpoint of VTE and VTE-related death, it did significantly reduce symptomatic VTE with consistent and favorable safety, reinforcing the positive benefit-risk profile of XARELTO®.

MAGELLAN and MARINER are part of the EXPLORER clinical research program for XARELTO®. As a collaborative effort between Janssen and its development partner Bayer, EXPLORER has generated important clinical evidence on the safety and efficacy of XARELTO®. Many studies in the program are designed to seek additional indications or expand the label for XARELTO® to benefit more patients in need of therapies for their cardiovascular disease. By the time of its completion, more than 275,000 patients will have participated in the EXPLORER program, other completed and ongoing clinical trials, investigative registries and non-interventional studies.

WHAT IS XARELTO®?

XARELTO® is a prescription medicine used to:

XARELTO® is used with low dose aspirin to:

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:

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:

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, who have a history of blood clots.

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 FDA at 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.

About Janssen Cardiovascular & Metabolism

In Cardiovascular & Metabolism (CVM), we take on the most pervasive diseases that burden hundreds of millions of people and healthcare systems around the world. As part of this long-standing commitment and propelled by our successes in treating type 2 diabetes (T2D) and thrombosis, we advance highly differentiated therapies that prevent and treat life-threatening cardiovascular, metabolic and retinal diseases. Uncovering new therapies that can improve the quality of life for this large segment of the population is an important endeavor ? one which Janssen CVM will continue to lead in the years to come. Our mission is global, and local and personal. Together, we can reshape the future of cardiovascular, metabolic and retinal disease prevention and treatment. Please visit www.janssen.com/cardiovascular-and-metabolism.

About the Janssen Pharmaceutical Companies of Johnson & Johnson

At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

Learn more at
www.janssen.com. Follow us at www.twitter.com/JanssenGlobal. Janssen Research & Development, LLC, is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Cautions Concerning Forward-Looking Statements

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding XARELTO® (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 December 30, 2018, 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. Neither 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 Dr. Alex C Spyropoulos served as a Member of the Steering Committee of the MAGELLAN trial and was compensated for his work.

i Kahn SR et al. Prevention of VTE in nonsurgical patients: antithrombotic therapy and prevention of thrombosis. 9th ed. American College of Chest Physicians Evidence-Based Clinical Practice Guideline. Chest 2012;141(suppl 2):e195S?e226S.

ii Spyropoulos AC et al. IMPROVE Investigators. Predictive and associative models to identify hospitalized medical patients at risk for VTE. Chest 2011;140:706?14.

iii Hull RD et al. Venous thromboembolism in elderly high-risk medical patients: time course of events and influence of risk factors. Clin Appl Thromb Hemost 2013;19:357?62.

iv Office of the Surgeon General, National Heart, Lung and Blood Institute. Publications and reports of The Surgeon General. The Surgeon General's Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism. Rockville, MD: Office of the Surgeon General (US); 2008.

v Mehta KD et al. Trends of Inpatient Venous Thromboembolism in United States Before and After the Surgeon General's Call to Action. Am J Cardiol. 2019;124:960?965.

vi Kahn SR et al. Prevention of VTE in nonsurgical patients: antithrombotic therapy and prevention of thrombosis. 9th ed. American College of Chest Physicians Evidence-Based Clinical Practice Guideline. Chest. 2012;141(suppl 2):e195S?e226S.

vii Schünemann et al. American Society of Hematology 2018 guidelines for management of venous thromboembolism: prophylaxis for hospitalized and nonhospitalized medical patients. Blood Advances. 2018;2:3198-3225.

viii Fanikos J et al. Adherence to Pharmacological Thromboprophylaxis Orders in Hospitalized Patients. Am J Med. 2010;123:536-541.

ix Cohen A et al. Rivaroxaban for Thromboprophylaxis in Acutely Ill Medical Patients. N Engl J Med. 2013;368:513-523.

x Spyropoulos A et al. Rivaroxaban for Thromboprophylaxis after Hospitalization for Medical Illness. N Engl J Med. 2018;379:1118-1127.

Media contacts:
Sarah Freeman
Mobile: (215) 510-4758
sfreem21@its.jnj.com

Andrew Wheatley
Mobile: (609) 664-1797
awheatle@its.jnj.com

Investor contacts:
Johnson & Johnson
Christopher DelOrefice
Office: (732) 524-2955

Lesley Fishman
Office: (732) 524-3922

SOURCE Janssen Pharmaceutical Companies of Johnson & Johnson


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