New data on Bayer’s Xarelto®

Bayer HealthCare has announced that new data from the clinical development programme for its oral anticoagulant Xarelto® (rivaroxaban) will be presented at the 54th American Society of Haematology (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.

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 US 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.