October 30, 2017
Bayer receives FDA approval for Xarelto® 10 mg once daily for the extended treatment of venous thromboembolism
Rivaroxaban (Xarelto®) 10 mg once daily significantly reduces the risk of recurrent venous thromboembolism compared with aspirin 100 mg once daily following at least six months of standard anticoagulation therapy / FDA approval based on data from the EINSTEIN CHOICE studyBerlin, October 30, 2017 - Bayer AG and its development partner Janssen
Research & Development, LLC advise that the U.S. Food and Drug Administration
(FDA) has approved a label update for their oral Factor Xa inhibitor Xarelto®
(rivaroxaban) to include a 10 mg once daily dose for the extended treatment of
recurrent venous thromboembolism (VTE) in the USA. This label update applies to
patients at a continued risk of deep vein thrombosis (DVT) and/or pulmonary
embolism (PE) who have already received at least six months of standard
anticoagulation therapy. It provides physicians with an opportunity to
strengthen the treatment paradigm of these patients from no treatment or
aspirin to rivaroxaban 10 mg.
"Patients who have previously suffered a VTE are often at increased risk of
experiencing another event if anticoagulant treatment is stopped," said Dr
Joerg Moeller, Member of the Executive Committee of Bayer AG's Pharmaceutical
Division and Head of Development. "The FDA approval of the 10 mg dose provides
physicians with an additional therapeutic option enabling them to continue the
extended treatment with the regimen that best suits the benefit-risk-assessment
of the individual patient."
The European Commission already approved an update to the label for Xarelto in
the EU at October 19th.
VTE, which includes pulmonary embolism, a clot that travels to the lung, and
deep vein thrombosis, a blood clot in a deep vein (often in the legs), has a
significant global impact and after heart attack and stroke, is the third most
common cause of cardiovascular death worldwide. The current treatment
recommendation for the prevention of recurrent venous thromboembolism is
anticoagulation therapy for three months or longer, depending on the balance
between the risk of recurrent VTE and the risk of bleeding.
About Xarelto® (Rivaroxaban)
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
- 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
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
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