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Bayer Extends Clinical Investigation of Rivaroxaban into Important Areas of
Unmet Medical Need in Arterial Thromboembolism
New studies expand investigation of rivaroxaban to more than 275,000
Berlin, August 29, 2014 - Bayer HealthCare and its development partner
Janssen Research & Development, LLC announced today an expansion of the
global clinical development programme for the oral Factor Xa inhibitor
rivaroxaban for the prevention of potentially deadly blood clots in
patients at risk of arterial thromboembolism. Three new studies will
investigate the efficacy and safety of rivaroxaban in:
• Patients who have suffered an embolic stroke of undetermined source
• Patients with peripheral artery disease (PAD) undergoing peripheral
• Patients who have had an acute coronary syndrome (ACS)
"Together with our partner Janssen, we are committed to further investigate
the potential benefits of rivaroxaban in areas of significant unmet medical
need," said Dr Joerg Moeller, Member of the Bayer HealthCare Executive
Committee and Head of Global Development. "Rivaroxaban is already approved
to prevent and treat more venous and arterial thromboembolic conditions
than any other novel oral anticoagulant. However, areas of unmet medical
need still exist where rivaroxaban could potentially benefit even more
patients at risk of the serious and often life-threatening diseases caused
by blood clots."
Rivaroxaban (Xarelto®) has already been approved for five indications in
seven distinct areas of use. Yet the global burden of thrombosis-related
diseases remains significant in a number of areas of unmet medical need.
While the ongoing programme for rivaroxaban, including Phase III studies
like COMPASS, COMMANDER-HF, MARINER, and EINSTEIN CHOICE, addresses some of
these, the medical need in three additional areas is still high:
• Embolic stroke of undetermined source (ESUS)
NAVIGATE ESUS is a global Phase III indication-seeking study, designed to
evaluate rivaroxaban in patients with embolic stroke of undetermined
source. The study will include approximately 7,000 patients and be
conducted in more than 25 countries.
ESUS accounts for approximately 25 per cent of ischaemic strokes, but there
is limited knowledge or data available to guide treatment decisions
regarding the secondary prevention of stroke in these patients. "The ROCKET
AF study showed that once-daily rivaroxaban was effective and
well-tolerated among patients who have atrial fibrillation with and without
previous stroke or transient ischaemic attack," said Dr Robert G. Hart,
M.D., Professor of Medicine (Neurology), McMaster University, Hamilton,
Ontario, Canada. "Based on the findings from ROCKET AF, we will investigate
the potential clinical value of once-daily rivaroxaban in preventing
recurrence of stroke in patients with embolic stroke of undetermined source
- an important unmet need in stroke prevention."
• Peripheral artery disease (PAD)
VOYAGER PAD will explore the potential benefits of rivaroxaban in reducing
thrombotic vascular complications in patients with peripheral artery
disease undergoing peripheral artery interventions. This global Phase III
indication-seeking study will enroll more than 5,000 patients across more
than 20 countries.
PAD affects approximately 202 million people worldwide, and the progressive
build-up of plaque inside the arteries can slowly reduce the blood flow to
the limbs and the heart. Patients with PAD are not only at an increased
risk of atherothrombotic events such as stroke, heart attack, or
cardiovascular death, but also of amputations and acute limb ischaemia.
"Building on the results of the ATLAS ACS 2-TIMI 51 study in acute coronary
artery disease, this study will investigate whether rivaroxaban can provide
similar protection to patients with symptomatic PAD undergoing peripheral
revascularisation procedures," said Prof William R. Hiatt, M.D., Professor
of Medicine / Cardiology, University of Colorado School of Medicine,
President CPC Clinical Research, Denver, USA.
• Acute Coronary Syndrome (ACS)
GEMINI ACS 1 is a global Phase II study, designed to evaluate rivaroxaban
for long-term prevention in patients who have suffered an acute coronary
syndrome (ACS). The study will include 2,000 - 3,000 patients in more than
10 countries. If successful, GEMINI ACS 1 will be followed by a
confirmatory, fully powered, global Phase III study.
The ATLAS ACS 2-TIMI 51 trial demonstrated that the Dual Pathway Strategy
of rivaroxaban 2.5 mg twice daily in combination with acetylsalicylic acid
(ASA) alone or with ASA plus clopidogrel or ticlopidine resulted in
significant reductions in cardiovascular death, heart attack, stroke and
stent thrombosis in selected high-risk patients who had an acute coronary
syndrome (ACS) event with elevated cardiac biomarkers. "As a next step we
will investigate the benefits of the Dual Pathway Strategy of rivaroxaban
in combination with single antiplatelet treatment, including the novel
antiplatelet agents, for long-term secondary prevention after ACS in a
broader range of patients," said Prof E. Magnus Ohman, M.D., Professor of
Medicine, Duke Clinical Research Institute, Durham, North Carolina, USA.
The extensive evaluation of rivaroxaban to protect different patient
populations at risk of venous and arterial thromboembolism (VAT), makes it
the most studied novel OAC in the world. The investigation of rivaroxaban
will include more than 275,000 patients in both clinical trials and real
About Xarelto® (Rivaroxaban)
Rivaroxaban is the most broadly indicated novel oral anticoagulant and is
marketed under the brand name Xarelto®. Xarelto is approved for five
indications across seven distinct areas of use:
• 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 deep vein thrombosis (DVT) in adults
• The treatment of pulmonary embolism (PE) in adults
• The prevention of recurrent DVT and PE 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
• The prevention of atherothrombotic events (cardiovascular death,
myocardial infarction or stroke) 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
Whilst licences may differ from country to country, across all indications
Xarelto is approved in more than 125 countries.
Rivaroxaban was discovered by Bayer HealthCare, and is being jointly
developed with Janssen Research & Development, LLC. Xarelto is marketed
outside the U.S. by Bayer HealthCare and in the U.S. by Janssen
Pharmaceuticals, Inc. (a Johnson & Johnson Company).
Anticoagulant medicines are potent therapies used to prevent or treat
serious illnesses and potentially life-threatening conditions. Before
initiating therapy 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, please visit https://prescribe.xarelto.com
To learn more about thrombosis, please visit
To learn more about Xarelto, please visit http://www.xarelto.com
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields
of health care, agriculture and high-tech materials. Bayer HealthCare, a
subgroup of Bayer AG with annual sales of EUR 18.9 billion (2013), is one
of the world’s leading, innovative companies in the healthcare and medical
products industry and is based in Leverkusen, Germany. The company combines
the global activities of the Animal Health, Consumer Care, Medical Care and
Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover, develop,
manufacture and market products that will improve human and animal health
worldwide. Bayer HealthCare has a global workforce of 56,000 employees (Dec
31, 2013) and is represented in more than 100 countries. More information
is available at http://www.healthcare.bayer.com
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