December 09, 2015

Not intended for U.S. and UK Media

Article in German newspaper Handelsblatt regarding Xarelto

Berlin, December 9, 2015 - The German newspaper Handelsblatt has published an article in connection with the anticoagulant Xarelto in its December 9, 2015 edition.

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: is

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 benefit-risk profile.

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 real-world studies.

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 surgery

- 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 To learn more about thrombosis, please visit To learn more about Xarelto, please visit

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

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Last updated: December 04, 2013 Copyright © Bayer AG