Bayer receives positive CHMP opinion for rivaroxaban for patients with coronary or peripheral artery disease
Positive CHMP opinion based on data from the largest Phase III rivaroxaban study, COMPASS / Once approved, rivaroxaban will be the only non-vitamin K antagonist oral anticoagulant (NOAC) indicated in combination with acetylsalicylic acid (ASA) for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk for ischaemic events
Not intended for U.S. and UK Media
Berlin, July 27, 2018 - The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for a new indication of Bayer´s oral Factor Xa inhibitor Xarelto® (rivaroxaban). The regimen of Xarelto 2.5 mg twice daily plus acetylsalicylic acid (ASA) 75 - 100 mg once daily will be indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk for ischaemic events.
The positive opinion is based on data from the COMPASS study, the largest Phase III study with rivaroxaban (27,395 patients), which showed that the rivaroxaban vascular dose, 2.5 mg twice daily, plus ASA 100 mg once daily reduced the risk of the composite of stroke, cardiovascular (CV) death and heart attack by 24% (relative risk reduction) compared with ASA 100 mg once daily alone in patients with CAD or PAD.
"Despite the use of Guideline recommended therapies for patients with CAD and PAD, event rates - including heart attack, stroke or even death - remain high," said Dr Joerg Moeller, Member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Head of Research and Development. "Today’s positive CHMP opinion takes us one step closer to providing these patients with an important new treatment option." Once approved, rivaroxaban will be the only non-vitamin K antagonist oral anticoagulant (NOAC) indicated in combination with acetylsalicylic acid (ASA) for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk for ischaemic events.
Cardiovascular disease, which includes CAD and PAD, is responsible for 17.7 million deaths every year, representing 31% of all global deaths (1). Additionally, patients suffering from this disease have a reduction in life expectancy of over 7 years (2). CAD and PAD are caused by atherosclerosis, a chronic, progressive condition which is characterized by a build-up of plaque in the arteries (3),(4). These patients are at risk of thrombotic events which may lead to disability, loss of limb and death.
Current treatment Guidelines recommend antiplatelet therapies such as ASA (5),(6); however this has been shown to be only modestly effective. Further improvements in antithrombotic care will require new approaches such as dual pathway inhibition for these patients in order to provide enhanced vascular protection and reduce the burden of cardiovascular events.
As well as demonstrating a significant reduction in the composite efficacy endpoint of major adverse cardiovascular events (MACE), data from the COMPASS study showed that the rivaroxaban vascular dose, 2.5 mg twice daily, plus ASA 100 mg once daily resulted in a significant reduction in stroke (42%) and CV death (22%) compared to ASA 100 mg once daily alone (relative risk reduction). Furthermore, the combination regimen was associated with a 20% improvement in net clinical benefit, defined as the reduction in stroke, CV death, and heart attack balanced against the most serious bleeding events.
Bleeding incidence rates were low, and while there was an increase in major bleeding, notably there was no significant increase in fatal or intracranial bleeding. Importantly, in the PAD patient population, the combination of major adverse limb events plus all major amputations of a vascular cause were reduced significantly. Therefore, this new treatment approach represents a major advance in the management of PAD patients who are at high risk of atherothrombotic events despite optimized antiplatelet therapy.
The results of the COMPASS study were first presented at ESC Congress 2017 and published simultaneously in The New England Journal of Medicine in August 2017 (7).
Separately, data from the COMPASS study are currently under review by the U.S. Food and Drug Administration (FDA) as part of a supplemental New Drug Application (sNDA) for two new indications for rivaroxaban: reducing the risk of major events such as CV death, heart attack or stroke in patients with chronic CAD and/or PAD, and for reducing the risk of acute limb ischemia in patients with PAD.
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 seven indications, protecting patients across 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) and 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 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 (cardiovascular death, myocardial infarction or stroke) after an Acute Coronary Syndrome in adult patients with elevated cardiac biomarkers and no prior stroke or transient ischaemic attack (TIA) when co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine
Whilst licences may differ from country to country, across all indications Xarelto is approved in more than 130 countries.
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 potent therapies used to prevent or treat serious illnesses and potentially life-threatening conditions. Before initiating and while continuing 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
To learn more about Xarelto, please visit www.xarelto.com
(1) World Health Organization. Cardiovascular Diseases Factsheet http://www.who.int/gho/publications/world_health_statistics/en/. Accessed April 2018.
(2) Crimmins E, Hayward M, Hiroshi U, et al. Life with and without heart disease among women and men over 50. J Women Aging 2008; 20(1-2): 5-19.
(3) NHS Choices. Coronary heart disease. https://www.nhs.uk/conditions/coronary-heart-disease/. Accessed April 2018.
(4) NHS Choices. Peripheral arterial disease. https://www.nhs.uk/conditions/peripheral-arterial-disease-pad/. Accessed April 2018.
(5) Montalescot G, Sechtem U, Achenbach S, et al. Eur Heart J 2013;34 :2949-3003.
(6) Aboyans V, Ricco JB, Bartelink ML, et al. Eur Heart J 2017;39(9):763-816.
(7) Eikelboom, JW, Connolly SJ, Bosch J, et al. Rivaroxaban with or without Aspirin in Stable Cardiovascular Disease. N Engl J Med 2017; 377:1319-1330.
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