Berlin, June 21, 2022 – The Ministry of Health, Labor and Welfare in Japan has approved the use of the oral Factor Xa inhibitor rivaroxaban (Xarelto™) (2.5 mg twice daily, used in combination with aspirin 81-100 mg once daily) to treat patients with peripheral artery disease (PAD) after revascularization. The approval is based on data from the Phase III VOYAGER PAD trial.
This study demonstrated a positive benefit-risk profile of starting Xarelto in combination with aspirin in patients with symptomatic PAD after a recent lower-extremity revascularization. It´s the first trial to demonstrate the benefits of dual pathway inhibition – with the anticoagulant Xarelto in combination with the antiplatelet aspirin – in these PAD patients at high risk of major adverse cardiovascular events (MACE) and especially major adverse limb events (MALE).
“This approval is an important advance for patients with PAD in Japan,” said Dr. Michael Devoy, Head of Medical Affairs & Pharmacovigilance of Bayer AG’s Pharmaceuticals Division and Chief Medical Officer at Bayer. “Xarelto shows a significant benefit in patients with PAD who remain at high risk for major thrombotic events post lower extremity revascularization. They are suffering from a disease which often goes undiagnosed and undertreated.”
About the VOYAGER PAD study
The Phase III VOYAGER PAD study included 6,564 patients from 542 sites across 34 countries worldwide. In the study, patients were randomized to receive either Xarelto 2.5 mg twice daily plus aspirin 100 mg once daily or aspirin 100 mg once daily alone. The primary efficacy endpoint was a composite of MALE and MACE, ie. acute limb ischemia, major amputation of a vascular etiology, heart attack (myocardial infarction, MI), ischemic stroke or cardiovascular death. The primary safety outcome was major bleeding according to the Thrombolysis in Myocardial Infarction (TIMI) classification.
About PAD
Cardiovascular diseases (CVD), including coronary artery disease (CAD) and peripheral artery disease (PAD), account for around 1 in every 3 deaths worldwide. Despite advances in management, CVDs continue to place a significant burden on healthcare and social care. PAD is a common circulatory problem in which narrowing of the arteries reduces blood flow, mainly to the lower limbs, increasing the risk for major CV events. PAD is estimated to affect over 200 million people worldwide.
About Rivaroxaban (Xarelto™)
Rivaroxaban is the most broadly indicated non-vitamin K antagonist oral anticoagulant (NOAC) worldwide and is marketed under the brand name Xarelto. Xarelto is approved for more venous and arterial thromboembolic (VAT) conditions than any other NOAC:
· The prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) with one or more risk factors
· The treatment of pulmonary embolism (PE) in adults
· The treatment of deep vein thrombosis (DVT) in adults
· The prevention of recurrent PE and/or DVT in adults
· The prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip replacement surgery
· The prevention of VTE in adult patients undergoing elective knee replacement surgery
· The prevention of atherothrombotic events after an Acute Coronary Syndrome in adult patients with elevated cardiac biomarkers when co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine
· The prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk for ischemic events when co-administered with acetylsalicylic acid (ASA)
· Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years after at least 5 days of initial parenteral anticoagulation treatment
· Thromboprophylaxis (prevention of VTE and VTE related events) in children aged two years and older with congenital heart disease who have undergone the Fontan procedure
Xarelto is approved in more than 130 countries, although the approved labelling, including the number of indications may differ from country to country. Since launch in 2008, more than 100 million patients have been treated.
Rivaroxaban was discovered by Bayer and is being jointly developed with Janssen Research & Development, LLC. Xarelto is marketed outside the U.S. by Bayer and in the U.S. by Janssen Pharmaceuticals, Inc. (Janssen Research & Development, LLC and Janssen Pharmaceuticals, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson).
Anticoagulant medicines are therapies used to prevent or treat serious illnesses and potentially life-threatening conditions. Before initiating treatment with anticoagulant medicines, physicians should carefully assess the benefit and risk for the individual patient.
Responsible use of Xarelto is a very high priority for Bayer, and the company has developed a Prescribers Guide for physicians and a Xarelto Patient Card for patients to support best practice.
To learn more about thrombosis, please visit www.thrombosisadviser.com and www.vascularadviser.com
To learn more about Xarelto, please visit www.xarelto.com
About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2021, the Group employed around 100,000 people and had sales of 44.1 billion euros. R&D expenses before special items amounted to 5.3 billion euros. For more information, go to www.bayer.com.
Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
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