September 24, 2015
Bayer's Xarelto® Approved in Japan for the Treatment and Secondary Prevention of Pulmonary Thromboembolism and Deep Vein Thrombosis
Japan of its oral Factor Xa inhibitor Xarelto® (rivaroxaban) for the treatment
and secondary prevention of pulmonary thromboembolism and deep vein thrombosis
by the Japanese Ministry of Health, Labor and Welfare (MHLW).
Deep vein thrombosis (DVT) is a condition in which blood clots form in one of
the large, deep veins, usually in the legs. Pulmonary embolism (PE) is a
condition that most commonly occurs when part or all of a DVT dislodges and
travels to the lung, via the heart, where it can partially or completely block
a branch of a pulmonary artery. When PE occurs with large clots, multiple
clots, or when the patient has pre-existing heart or lung disease, the event
may be fatal. On average, every 37 seconds someone in the Western World dies
from a venous blood clot, making PE and DVT (known collectively as Venous
Thromboembolism, VTE) the third most common cardiovascular condition.
"Xarelto provides fast and effective treatment for patients suffering from PE
and DVT. While the overall rates of major bleeding and clinically relevant
non-major bleeding as the primary endpoint were comparable, Xarelto nearly
halved the risk of major bleeding compared with the conventional dual-drug
treatment approach", said Dr Joerg Moeller, Member of the Bayer HealthCare
Executive Committee and Head of Global Development. "With the approval of
Xarelto for the treatment and secondary prevention of pulmonary thromboembolism
and deep vein thrombosis, we can now provide physicians and patients in Japan
with the first oral treatment without the need for injections."
Today's MHLW approval of Xarelto is based on data from the global EINSTEIN
Clinical Trial Programme, and is supported by the J-EINSTEIN studies
(J-EINSTEIN DVT and J-EINSTEIN PE), which were run entirely in Japan. The
EINSTEIN Clinical Trial Programme demonstrated the efficacy and safety profile
of rivaroxaban in the treatment of patients with acute symptomatic PE or DVT
and the prevention of recurrent PE and DVT in these patients.
About Xarelto® (Rivaroxaban)
Rivaroxaban is the most broadly indicated non-vitamin K antagonist oral
anticoagulant (NOAC) 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 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 130 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. (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
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 and agriculture. 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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