Bayer receives EU approval for Xarelto®▼ 10 mg once daily for the extended prevention of venous thromboembolism
Xarelto® (rivaroxaban) 10 mg once daily significantly reduces relative risk of recurrent venous thromboembolism by 74% (absolute risk reduction of 3.2%), providing superior protection compared with aspirin 100 mg once daily after at least six months of standard anticoagulation therapy
Approval based on data from the EINSTEIN CHOICE study
Reading, UK, 01 November 2017 – Bayer AG and its development partner Janssen Pharmaceuticals, Inc. today announced that the European Commission (EC) has approved an update to the label of its oral Factor Xa inhibitor Xarelto® (rivaroxaban) to include a 10 mg once daily dose for the extended prevention of recurrent venous thromboembolism (VTE). This label update applies to patients who have already received at least six months of standard anticoagulation therapy, and provides clinicians with an additional treatment option alongside the 20 mg once daily dose already licensed in this indication.
Dr Alexander T. Cohen, Principal study investigator, Guys & St Thomas’ Hospitals, Kings College London, said: “This is welcome news for clinicians across the UK, providing us with an effective, dose-specific option to reduce the risk of recurrent VTE. In the past there has been uncertainty about how to manage ongoing anticoagulation therapy, but this announcement means we can confidently treat high risk patients and reduce the number of VTE-related deaths, while improving the lives of those who live under the constant threat of a recurrent VTE.”
VTE, which includes pulmonary embolism (PE), a clot that travels to the lung, and deep vein thrombosis (DVT), a blood clot in a deep vein (often in the legs), has a significant global impact and is the third most common cause of cardiovascular disease worldwide, after heart attack and stroke.1,2 DVT affects as many as one in every 1,000 people in the UK, while PE affects 86 in every 100,000,3 and each year more than 25,000 people in the UK die from VTE.4 The current treatment recommendation for the prevention of recurrent VTE is anticoagulation therapy for three months or longer, depending on the balance between the risk of recurrent VTE and the risk of bleeding.5 However, the risk of patients with unprovoked VTE or with ongoing risk factors experiencing a second event is up to 10% in the first year if treatment is stopped.6
Dr Luis Felipe Graterol, Medical Director, Bayer UK, said: “We are delighted with the European Commission’s approval of Xarelto® 10 mg for the prevention of recurrent VTE in the UK. This provides clinicians with wider therapeutic options and the ability to prescribe more precise and individualised doses to patients who are at high risk from recurrent VTE and bleeding. Bayer is committed to supporting better care and outcomes for people with a wide range of cardiovascular conditions in the UK.”
The EC approval is based on data from the Phase III EINSTEIN CHOICE study involving 3,396 patients, which showed that both 10 mg and 20 mg once daily dosages of Xarelto® significantly reduced the risk of recurrent VTE compared with aspirin 100 mg once daily (acetylsalicylic acid), in patients who had previously completed six to 12 months of anticoagulation therapy for treatment of PE and / or symptomatic DVT.7 All three treatment groups showed comparable and very low rates of major bleeding (the principle safety outcome).7 Importantly, patients with a definitive need for continued therapeutic anticoagulation beyond the first six to 12 months were not included in the study.7 Data from EINSTEIN CHOICE were presented at the American College of Cardiology (ACC) 6th Annual Scientific Sessions and published in The New England Journal of Medicine in March 2017.7
Reporting of side effects:
This medicine is subject to additional monitoring ▼. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See www.mhra.gov.uk/yellowcard for how to report side effects.
About Xarelto® (Rivaroxaban)
The extensive clinical development programme for rivaroxaban evaluating/ investigating the protection of different patient populations at risk of venous and arterial thromboembolism (VAT) makes it the most studied novel OAC in the world. To date, Xarelto® has been approved for use in more than 125 countries, across all indications, and in the UK specifically to date across the following indications8:
- The prevention of stroke and systemic embolism in adult patients with non-valvular AF with one or more risk factors
- The treatment of deep vein thrombosis (DVT) and pulmonary embolism (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
- The prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers, co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine
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. (a Johnson & Johnson Company). Anticoagulant medicines are potent therapies used to prevent and treat blood clots the consequences of which may be serious, or to 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 ‘Prescriber’s Guide’ for physicians and a ‘Xarelto Patient Card’ for patients to support best practice.
Bayer: Science For A Better Life
Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At the same time, the Group aims to create value through innovation, growth and high earning power. Bayer is committed to the principles of sustainable development and to its social and ethical responsibilities as a corporate citizen. In fiscal 2016, the Group employed around 115,200 people and had sales of EUR 46.8 billion. Capital expenditures amounted to EUR 2.6 billion, R&D expenses to EUR 4.7 billion. These figures include those for the high-tech polymers business, which was floated on the stock market as an independent company named Covestro on October 6, 2015. For more information, go to www.bayer.com.
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer 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 Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
1 Patient UK. Deep vein thrombosis. 2015. Available at: http://www.patient.co.uk/health/Deep-Vein-Thrombosis.htm [Last accessed October 2017]
2 Naess IA, Christiansen SC, Romundstad P, et al. Incidence and mortality of venous thrombosis: a population-based study. J Thromb Haemost. 2007;5(4):692-99
3 Anticoagulation Europe. 2013. From prevention to treatment: Deep vein thrombosis and pulmonary embolism. Available at: http://www.anticoagulationeurope.org/publications/from-prevention-to-treatment-deep-vein-thrombosis-and-pulmonary-embolism [Last accessed October 2017]
4 National Clinical Guideline Centre – Acute and Chronic Conditions. 2010. Venous thromboembolism: reducing the risk of venous thromboembolism (deep vein thrombosis and pulmonary embolism) in patients admitted to hospital. Available at: https://www.nice.org.uk/guidance/cg92 [Last accessed October 2017]
5 Kearon C, Akl EA, Ornelas J, et al. Antithrombotic therapy for VTE disease: CHEST guideline and expert panel report. Chest 2016;149(2):315-52
6 Weitz JI, Bauersachs R, Beyer-Westendorf J, et al. Two doses of rivaroxaban versus aspirin for prevention of recurrent venous thromboembolism. Rationale for and design of the EINSTEIN CHOICE study. J Thromb Haemost. 2015;114:645-50
7 Weitz JI, Lensing AWA, Prins MH, et al. Rivaroxaban or aspirin for extended treatment of venous thromboembolism. N Engl J Med 2017;376(13):1211-22
8 eMC. 2017. Xarelto SPC. Available at: https://www.medicines.org.uk/emc/medicine/25586 [Last accessed October 2017]