NEWBURY, England--(BUSINESS WIRE)--News release for UK media only
Bayer AG and its cooperation partner Janssen Research & Development, LLC today announced that the Phase III trial COMPASS study evaluating the efficacy and safety of rivaroxaban (Xarelto®) for the prevention of major adverse cardiac events (MACE) including cardiovascular death, myocardial infarction and stroke in patients with coronary artery disease (CAD) or peripheral artery disease (PAD) has met its primary endpoint ahead of time.
Following a planned interim analysis conducted by the independent Data Monitoring Committee (DMC), the DMC recommended to stop the trial early as the primary MACE endpoint has reached its prespecified criteria for superiority. Owing to the magnitude of effect and the confirmation of the existing safety profile of rivaroxaban, Bayer, Janssen and the Population Health Research Institute (PHRI) will offer rivaroxaban to study participants in an open-label extension trial. The COMPASS study is the largest clinical study of rivaroxaban to date.1
The Phase III COMPASS study was conducted in collaboration with the PHRI and has enrolled 27,402 patients from more than 600 sites across more than 30 countries worldwide. In the study, patients were randomised to receive either rivaroxaban 2.5 mg twice daily in addition to aspirin 100 mg once daily, rivaroxaban 5 mg twice daily alone, or aspirin 100 mg once daily alone.1
A complete data analysis from this study is expected to be presented at an upcoming medical meeting in 2017.
“Despite established and effective treatments, an unmet medical need in this patient population still exists with rates of CAD and PAD rising globally,” said Dr Joerg Moeller, Member of the Executive Committee of Bayer AG's Pharmaceutical Division and Head of Development. “Bayer is committed to an ongoing clinical development programme that addresses such unmet medical needs. We are excited about these results and look forward to making rivaroxaban available to appropriate patients with CAD and PAD to reduce their risk of major adverse cardiac events.”
Coronary artery disease (CAD) is the most common cause of cardiovascular disease and is responsible for approximately 7.3 million deaths worldwide every year. One-third to one-half of all middle-aged men and women in high income countries are at risk of developing CAD during their lifetime, and the number of people with CAD is rising globally. By 2020, the burden of coronary artery disease is projected to reach 82 million disability-adjusted life years (DALYs) or “healthy years of life lost”.
Peripheral artery disease (PAD), while often undiagnosed, affects over 27 million people in Europe and North America and is an important risk marker of cardiovascular disease. Globally, screening studies suggest that approximately 20% of adults older than 55 years have evidence of PAD. The disease prevalence is strongly age-related and, like CAD, the numbers of affected patients is rising, because of the aging of the population. COMPASS is part of the extensive investigation of rivaroxaban, which, by the time of its completion, is expected to include more than 275,000 patients in both clinical trials and real-world settings.
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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 indications:2
- 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.
Since the first approval of Xarelto in the orthopaedic setting in 2008, 23 million patients worldwide have received Xarelto in daily clinical practice.3
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 2015, the Group employed around 117,000 people and had sales of EUR 46.3 billion. Capital expenditures amounted to EUR 2.6 billion, R&D expenses to EUR 4.3 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.co.uk
Forward Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup 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. Cappato R. et al. COMPASS PAD study design. ‘Exploring unmet needs in venous and arterial thromboembolism with rivaroxaban’.
2. eMC. Xarelto SPC. Available at: https://www.medicines.org.uk/emc/medicine/25586 [Last accessed February 2017].
3. Data on File, Bayer
Date of Preparation: February 2017