TITUSVILLE, NJ, October 11, 2018 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved Xarelto (rivaroxaban) to reduce the risk of major cardiovascular (CV) events, such as CV death, myocardial infarction (MI) and stroke, in people with chronic coronary or peripheral artery disease (CAD/PAD). Xarelto is now the first and only Factor Xa inhibitor approved for patients living with these conditions.
This new indication is based on results from the landmark COMPASS trial, which showed a significant 24% reduction of the risk of major CV events in patients with chronic CAD and/or PAD with the Xarelto 2.5-mg vascular dose twice daily plus aspirin 100 mg once daily, compared to aspirin alone. This finding was driven by a 42% reduction in stroke, 22% reduction in CV death and 14% reduction in heart attack. The risk of major bleeding was significantly higher in patients taking the Xarelto/aspirin regimen compared to aspirin alone, with no significant increase in fatal or intracranial bleeds.
“Despite the use of guideline-recommended therapies, patients with chronic CAD and/or PAD remain at risk of having a devastating and irreversible CV event,” said Paul Burton, MD, PhD, FACC, Vice President, Medical Affairs, Internal Medicine, Janssen Scientific Affairs, LLC. “The new Xarelto vascular 2.5-mg dose, when used with aspirin, represents a true breakthrough for patients with chronic CAD and PAD.”
“Treating patients with aspirin only is simply not enough to address the underlying thrombotic risk that comes with chronic CAD and PAD,” said Kelley Branch[i], MD, MSc, FACC, FSCCT, Associate Professor in Cardiology, University of Washington, Seattle. “As we saw in the COMPASS trial, the dual pathway approach of aspirin and the 2.5-mg, twice-daily dose of Xarelto can help significantly reduce the risk of CV events in these populations.”
Both chronic CAD and PAD occur when arteries become hardened or narrowed due to a buildup of cholesterol and plaque, potentially limiting blood flow to parts of the body. Known as atherosclerosis, this disease is rarely fatal, but is the most frequent underlying cause of chronic CAD and PAD, which affect 16.5 million and 10 million Americans, respectively[ii], 13 million of whom are currently diagnosed. When left untreated, atherosclerosis can lead to serious problems, including heart attack, stroke and death.
COMPASS, a Phase 3 clinical study of 27,395 patients with chronic CAD or PAD from 33 countries, examined the use of Xarelto, alone or in combination with aspirin, for the long-term prevention of major adverse CV events, including heart attack, stroke and CV death. In February 2017, COMPASS was stopped early for efficacy based on recommendation of the Independent Data and Safety Monitoring Board who observed a consistent difference in the primary outcome in favor of Xarelto 2.5 mg plus aspirin. The COMPASS results were presented during a Hot Line session at the ESC Congress 2017 and simultaneously published in The New England Journal of Medicine. Two sub-analyses from COMPASS in patients with PAD and CAD were also published in The Lancet.
COMPASS is a part of the industry-leading EXPLORER clinical development program, a collaborative effort between Janssen and Bayer, which seeks to generate important clinical evidence on the safety and efficacy of Xarelto and its potential role in addressing a wide range of critical medical needs.
In July 2018, Janssen’s development partner Bayer announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) granted a positive opinion to update the Xarelto label to include the new vascular indication in the European Union; the European Commission granted approval on August 24, 2018. Since its launch, Xarelto has been approved for a variety of indications and prescribed more than 45 million times worldwide.
What is Xarelto?
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
Xarelto is also used with low dose aspirin to:
- reduce the reduce the risk of serious heart problems, heart attack and stroke in patients with coronary artery disease (a condition where the blood supply to the heart is reduced or blocked) or peripheral arterial disease (a condition where the blood flow to the legs is reduced)
It is not known if Xarelto is safe and effective in children.
About the Janssen Pharmaceutical Companies
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science.
We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com. Follow us on Twitter at @JanssenUS. Janssen Pharmaceuticals, Inc. and Janssen Scientific Affairs, LLC are 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 product development and the presentation of new data and analyses 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 Pharmaceuticals, Inc., Janssen Scientific Affairs, 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 31, 2017, 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.
Source: Janssen Pharmaceutical Companies
Posted: October 2018
- FDA Approves New 10 mg Dosing for Xarelto (rivaroxaban) to Reduce the Continued Risk of Venous Thromboembolism (VTE) – October 30, 2017
- FDA Issues Complete Response Letter for Xarelto (rivaroxaban) to Reduce the Risk of Stent Thrombosis in Patients with Acute Coronary Syndrome – June 28, 2013
- FDA Expands Use of Xarelto to Treat, Reduce Recurrence of Blood Clots – November 2, 2012
- FDA Approves Xarelto to Prevent Stroke in People With Common Type of Abnormal Heart Rhythm – November 4, 2011
- FDA Approves Xarelto (rivaroxaban) to Prevent Deep Vein Thrombosis in Patients Undergoing Knee or Hip Replacement Surgery – July 1, 2011
- New Drug Application Submitted to FDA for Rivaroxaban for Prevention of Stroke in Patients with Atrial Fibrillation – January 5, 2011
- New Drug Application for Rivaroxaban in the U.S. – July 16, 2009
- U.S. FDA Issues Complete Response Letter for Rivaroxaban – May 28, 2009
- FDA Advisory Committee Finds Favorable Risk-Benefit Profile for Oral Anticoagulant Rivaroxaban for Prophylaxis of Deep Vein Thrombosis and Pulmonary Embolism After Hip or Knee Replacement Surgery – March 20, 2009
- Venous Blood Clot Prevention after Hip or Knee Replacement Surgery: Bayer’s Novel Anticoagulant Rivaroxaban Submitted for Approval in the U.S. – July 30, 2008
Xarelto (rivaroxaban) FDA Approval History
Source: Read Full Article