Press Release
54th American Society of Hematology (ASH) Annual Meeting and Exposition 2012:
New data on Bayer’s Xarelto® (Rivaroxaban) as a Single-Drug Solution for the Treatment of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE)
- Pooled data from EINSTEIN trials show oral rivaroxaban has an improved benefit-risk profile and lower rates of major bleeding compared with standard therapy
- New data also show reduced hospital stay and improved patient-reported satisfaction with rivaroxaban for patients with acute symptomatic PE
Nov 30th, 2012 - Berlin, Germany - Bayer HealthCare announced today that new data from the clinical development programme for its oral anticoagulant Xarelto (rivaroxaban) will be presented at the 54th American Society of Hematology (ASH) Annual Meeting and Exposition in Atlanta, GA, USA, December 8-11, 2012. These data underscore the benefits of rivaroxaban for patients at risk of dangerous blood clots across multiple venous thromboembolic conditions.
Notable data analyses to be presented at ASH 2012 include:
- Oral Rivaroxaban for the Treatment of Symptomatic Venous Thromboembolism: A Pooled Analysis of the EINSTEIN DVT and EINSTEIN PE Studies
- Oral Presentation: Session 332. Antithrombotic Therapy I; 12:15
- Saturday, December 8, 2012; 12:00 - 13:30; Georgia World Congress Center, B405-B407
- Patient-Reported Treatment Satisfaction with Oral Rivaroxaban versus Standard Therapy in the Treatment of Acute Symptomatic Pulmonary Embolism
- Poster Session: Session 332. Antithrombotic Therapy: Poster I
- Saturday, December 8, 2012; 17:30 - 19:30; Georgia World Congress Center, Hall B1-B2
- Reduction in Initial Length of Stay with Rivaroxaban Single-Drug Regimen versus LMWH-VKA Standard of Care: Findings from the EINSTEIN Trial Program
- Poster Session: Session 332. Antithrombotic Therapy: Poster III
- Monday, December 10, 2012; 18:00 - 20:00; Georgia World Congress Center, Hall B1-B2
The pivotal EINSTEIN Clinical Trial Programme comprises three Phase III studies evaluating rivaroxaban alone versus the dual-drug regimen of low molecular weight heparin (LMWH) and vitamin K antagonist (VKA) in the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and the prevention of recurrent DVT and PE.
Xarelto has been approved as a single-drug solution for the treatment of DVT and PE as well as the prevention of recurrent DVT and PE in adults in a number of countries worldwide including Europe and the U.S.
About Xarelto (Rivaroxaban)
Rivaroxaban is the most broadly indicated new oral anticoagulant and is marketed under the brand name Xarelto. To date, Xarelto is approved for use in the following venous arterial thromboembolic (VAT) indications:
- 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) and prevention of recurrent DVT and pulmonary embolism (PE) in adults
- The treatment of PE and prevention of recurrent DVT and PE in adults
- The prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery
Whilst licences may differ from country to country, across all indications Xarelto is approved in more than 120 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 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 EUR 17.2 billion (2011), 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 55,700 employees (Dec 31, 2011) and is represented in more than 100 countries. More information at www.healthcare.bayer.com.
Our online press service is just a click away: press.healthcare.bayer.com
Contact:
Astrid Kranz, Tel. +49 30 468-12057
E-Mail: astrid.kranz@bayer.com
Find more information at www.bayerpharma.com.
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Forward-Looking Statements
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our annual and interim reports to the Frankfurt Stock Exchange and in our reports filed with the U.S. Securities and Exchange Commission (including our Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
- Deep vein thrombosis
- A blood clot in a deep vein, usually resulting from damage to the vein or blood flow slowing down or stopping. Usually DVTs are found in the leg, but can also be in the arm. Distal DVTs are found in deep veins of the calf, and are the most common type of DVT. Proximal DVTs are found in the legs above the calf muscle up to the waist.
- Pulmonary embolism
- A potentially fatal condition caused by a blood clot blocking a vessel in the lung: usually the clot originates from a DVT in the legs. PE can result in permanent lung damage.
- Low molecular weight heparin
- An anticoagulant used to prevent new clots forming and existing clots from getting larger. It is injected subcutaneously (under the skin).
- Thrombosis
- Formation of a clot inside a blood vessel.
- Atrial fibrillation
- A heart rhythm disorder where chambers in the upper heart (atria) beat more rapidly than those in the lower section of the heart. Blood is not pumped out of the upper chambers completely during beating, and may pool and form a clot. A stroke results if a section of clot dislodges from the upper chambers and becomes lodged in the brain.
- Venous thromboembolism
- A disease process beginning with a blood clot occurring within the venous system, including deep vein thrombosis and pulmonary embolism.
