May 04, 2015
Bayer's Xarelto® Approved in China for Stroke Prevention in Patients with Non-Valvular Atrial Fibrillation and for the Treatment of Deep Vein Thrombosis
Xarelto is now approved in China across three indications in the area of venous and arterial thromboembolismBerlin, May 4, 2015 - Bayer's once-daily oral anticoagulant Xarelto®
(rivaroxaban) has been approved by the China Food and Drug Administration
(CFDA) for the prevention of stroke and systemic embolism in adult patients
with non-valvular atrial fibrillation with one or more risk factors.
Additionally, the CFDA has approved Xarelto for the treatment of deep vein
thrombosis (DVT) and for the reduction of the risk of recurrent DVT and
pulmonary embolism (PE) following an acute DVT in adults. Since 2009, Xarelto
has been available in China for the prevention of venous thromboembolism (VTE)
in adult patients undergoing elective hip or knee replacement surgery.
"This approval is the result of many years of research and a robust development
program," said Dr. Joerg Moeller, Member of the Bayer HealthCare Executive
Committee and Head of Global Development. "We are delighted to bring the
benefits of Xarelto to patients and physicians in China in need of an effective
and convenient therapy against blood clots to prevent strokes and treat DVT."
The approval of rivaroxaban for the prevention of stroke in patients with
atrial fibrillation by the China Food and Drug Administration is based on the
clinical benefits demonstrated in ROCKET AF, a double-blind global Phase III
study that compared once-daily rivaroxaban with warfarin in more than 14,000
patients. 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
The extensive evaluation of rivaroxaban to protect different patient
populations at risk of venous and arterial thromboembolism (VAT) makes it the
most studied novel oral anticoagulant in the world. The investigation of
rivaroxaban is planned to include more than 275,000 patients in both clinical
trials and real world settings.
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, protecting patients across more
venous and arterial thromboembolic (VAT) conditions than any other novel oral
- 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 replacement
- 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 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 www.thrombosisadviser.com
To learn more about Xarelto, please visit 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 around EUR 20.0 billion (2014), 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 60,700 employees (Dec 31,
2014) and is represented in more than 100 countries. More information is
available at www.healthcare.bayer.com.
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