December 09, 2015
Article in German newspaper Handelsblatt regarding Xarelto
article in connection with the anticoagulant Xarelto in its December 9, 2015
The company comments on this article as follows:
Bayer has conducted a number of sensitivity analyses, which confirm the results
of the ROCKET AF study and the positive benefit-risk profile of Xarelto
(rivaroxaban) in patients with non-valvular atrial fibrillation. Bayer is
working closely with health authorities to address any questions they may have.
Separately, the ROCKET AF Executive Committee under the leadership of the Duke
Clinical Research Institute (DCRI) at Duke University, Durham, North Carolina,
who ran the ROCKET AF trial, conducted their own, independent analysis of
ROCKET AF following the device correction notice. The conclusion of their
analysis has been published on the DCRI website:
Xarelto is an important anticoagulant used to treat and reduce the risk of
life-threatening blood clots. Beyond ROCKET AF, Bayer evaluated the performance
of Xarelto in more than 91,000 patients across its approved indications in
real-world research following the medicine's approval, and study after study
continues to confirm that Xarelto is performing as expected with a positive
This is further supported by evidence generated through independent
post-marketing studies conducted by regulators and clinicians as well as our
study XANTUS which investigated the use of Xarelto in more than 6,700 SPAF
patients in routine clinical practice.
More than 55,000 patients have been evaluated in indication seeking trials and
more than 91,000 patients have been assessed in global, post-approval
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 NOAC:
- 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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Find more information at www.bayerpharma.com.