December 19, 2011
Bayer's Xarelto® Approved in the EU for the Prevention of Stroke in Patients with AF and in the Treatment of DVT
In stroke prevention in AF, Xarelto is the only oral anticoagulant offering patients a once-daily, highly effective therapy without need for routine coagulation monitoring / For the treatment of DVT and the prevention of recurrent DVT and PE, Xarelto is the first oral anticoagulant to offer patients both efficacy and the convenience of a single-drug solution, without the need for injections or monitoring / Xarelto is now approved in the EU across three indications in the area of venous and arterial thromboembolism (VAT)Berlin, Germany, December 19, 2011 - Bayer HealthCare's oral anticoagulant
Xarelto® (rivaroxaban) has been approved by the European Commission (EC) for
use in two new indications, making it the only new oral anticoagulant approved
in three indications across all 27 EU member states:
- Prevention of stroke and systemic embolism in adult patients with
non-valvular atrial fibrillation (AF) with one or more risk factors
- Treatment of deep vein thrombosis (DVT) and prevention of recurrent DVT and
pulmonary embolism (PE) following an acute DVT in adults
- The prevention of VTE in adult patients undergoing elective hip or knee
"Today's approval in these new indications by the European Commission marks the
culmination of years of intensive research, and underscores Bayer's innovative
strength," said Dr. Jörg Reinhardt, Chairman of the Bayer HealthCare Executive
Committee. "We are delighted to bring the benefits of rivaroxaban to patients
and physicians in the EU in need of a highly effective and convenient therapy
against blood clots to prevent strokes and treat DVT."
"These approvals have the potential to change clinical practice in Europe,"
said Professor Alexander G.G. Turpie, Professor of Medicine, McMaster
University, Canada. "Rivaroxaban offers patients suffering from AF an effective
and well-tolerated therapy option, while avoiding the drawbacks of traditional
therapies. In the treatment of DVT and prevention of recurrent DVT and PE,
physicians are now able to utilise a new single drug solution, making the
therapy more convenient for both patients and physicians."
The approval of rivaroxaban for the prevention of AF-related stroke is based on
the important clinical benefits demonstrated in ROCKET AF, a rigorous,
double-blind global Phase III study that compared once-daily rivaroxaban with
warfarin in more than 14,000 patients. The results from the ROCKET AF trial
were published in the New England Journal of Medicine (NEJM) in August 2011.
The approval of rivaroxaban for the treatment of DVT and the prevention of
recurrent DVT and PE following an acute DVT, follows submission of data from
the Phase III EINSTEIN-DVT study, as well as data from the Phase III
EINSTEIN-Extension study. Both EINSTEIN-DVT and EINSTEIN-Extension were
published in the NEJM in December 2010.
"The decision of the European Commission to approve this therapy is welcome
news for people at risk of the devastating consequences of blood clots," said
Eve Knight, Co-Founder and CEO of the charity AntiCoagulation Europe (ACE).
"Thrombosis remains a massive burden on patients and healthcare systems across
the EU, and the approval of effective alternatives without the limitations of
traditional therapies such as routine monitoring, regular injections and
dietary challenges represents a much needed evolution in thrombosis management."
About Venous and Arterial Thromboembolism (VAT)
Thrombosis is the formation of a blood clot inside a blood vessel, blocking a
vein (venous thrombosis) or artery (arterial thrombosis). Venous and Arterial
Thromboembolism (VAT) is caused when a clot becomes loose and is moved by the
blood stream to obstruct another vessel, which can cause damage to vital
organs. VAT encompasses two serious conditions:
- Venous Thromboembolism (VTE) occurs when part of a clot formed in a deep
vein, for example in the leg (known as deep vein thrombosis, or DVT), is
carried to another vessel which delivers blood to an organ. If this occurs in a
vessel supplying blood to the lungs, it is known as a pulmonary embolism (PE),
which can be rapidly fatal.
- Arterial Thromboembolism (ATE) occurs when oxygenated blood flow from the
heart to another part of the body (via an artery) is interrupted by a blood
clot. If this occurs in a vessel supplying the brain, this can lead to a
stroke, which can be severely debilitating or fatal. If it occurs in a coronary
artery, it can lead to acute coronary syndrome (ACS), a complication of
coronary heart disease which includes conditions such as myocardial infarction
(heart attack), and unstable angina.
VAT is an important cause of morbidity and mortality across a broad range of
acute and chronic blood-clotting disorders and requires active or preventative
treatment to avoid potentially serious or fatal patient outcomes.
About Atrial Fibrillation
Atrial fibrillation is the most common sustained cardiac rhythm disorder and
affects more than 6 million people in Europe. People with AF are at a five-fold
increased risk for stroke compared with the general population, and about
one-third of them will suffer a stroke. An irregular heartbeat makes AF
patients vulnerable to the formation of a blood clot in the atria of the heart,
and this can travel to the brain, potentially resulting in a stroke. Strokes
damage the brain, and can lead to both physical and behavioural impairment, or
About Deep Vein Thrombosis (DVT)
Venous Thromboembolism (VTE) is caused by the obstruction of a blood vessel by
a blood clot. In the EU there are approximately 550,000 VTE related deaths each
year and it is estimated to be the third most common cardiovascular disease
after heart disease and stroke. Indeed, venous blood clots kill more people in
Europe each year than breast cancer, prostate cancer, HIV / AIDS and road
traffic accidents combined.
DVT is the formation of a blood clot in a deep vein that partially or totally
blocks the flow of blood. However, DVT can progress to become a potentially
fatal PE if the blood clot breaks apart and travels to the lungs, ultimately
blocking a blood vessel there. Even in the absence of a PE, DVT alone can have
devastating and costly consequences such as post-thrombotic syndrome and an
increased risk of recurring blood clots, and thus the achievement of treatment
goals is critically important. The current treatment standard for DVT includes
two drugs, low molecular weight heparin administered by subcutaneous injection,
followed by a vitamin K antagonist, a complex and often problematic regimen.
Rivaroxaban is an oral anticoagulant that was discovered in Bayer HealthCare's
Wuppertal laboratories in Germany, and is being jointly developed by Bayer
HealthCare and Janssen Research & Development, L.L.C. (a Johnson & Johnson
Company). It has a rapid onset of action with a predictable dose response and
high bioavailability, no requirement for routine coagulation monitoring or
regular renal monitoring, as well as a limited potential for food and drug
Rivaroxaban is marketed under the brand name Xarelto® for VTE prevention in
adult patients following elective hip or knee replacement surgery, and it is
the only oral anticoagulant that has consistently demonstrated superior
efficacy over enoxaparin in this indication. Rivaroxaban is approved in more
than 110 countries worldwide and marketed outside the U.S. by Bayer HealthCare
in this indication.
In the U.S., where rivaroxaban has been available since July 2011 for VTE
prevention in adult patients following elective hip or knee replacement
surgery, Janssen Pharmaceuticals, Inc. holds marketing rights. The Bayer
HealthCare sales force is supporting Janssen Pharmaceuticals, Inc. in
designated hospital accounts. On November 4, rivaroxaban received further
marketing approval in the U.S. to reduce the risk of stroke in patients with
The extensive clinical trial program supporting rivaroxaban makes it the most
studied and widely published oral, direct Factor Xa inhibitor. The studies,
reported and ongoing, involve over 75,000 patients for the prevention and
treatment of venous and arterial thromboembolic (VAT) disorders across a broad
range of acute and chronic conditions, including stroke prevention in patients
with Atrial Fibrillation, DVT treatment and the prevention of recurrent DVT or
PE, and the secondary prevention of Acute Coronary Syndrome.
To learn more about thrombosis, please visit www.thrombosisadviser.com.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of
health care, nutrition and high-tech materials. Bayer HealthCare, a subgroup of
Bayer AG with annual sales of EUR 16.9 billion (2010), 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 and manufacture products that
will improve human and animal health worldwide. Bayer HealthCare has a global
workforce of 55,700 employees (Dec 31, 2010) and is represented in more than
100 countries. Find more information at www.bayerhealthcare.com.
Find more information at www.bayerpharma.com.