For the Press
In the European Union Xarelto® is indicated for the prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery. The active compound of Xarelto, rivaroxaban, is being studied in a number of other indications.
The Press Resources page is designed to give you online access to timely and relevant information about Xarelto. In this section you will find information and resources for journalists, including current and archived press releases as well as a collection of background information and images related to Xarelto.
What is Xarelto(Rivaroxaban)?
Xarelto is a highly effective, oral anticoagulant developed to prevent and treat dangerous blood clots in a wide range of patients with or at threat from venous or arterial blood clots. Xarelto has the potential to improve clinical outcomes and quality of life for a wide range of patients with, or at risk of thromboembolism in a broad range of clinical settings.
What is Xarelto(Rivaroxaban) approved for?
Xarelto is currently approved in more than 110 countries worldwide for the prevention of venous thromboembolsim (VTE) in adult patients undergoing total elective hip or knee replacement surgery. It has been successfully launched in more than 85 countries by Bayer HealthCare Pharmaceuticals to date, including the United States, where Janssen Pharmaceuticals, Inc. (a Johnson & Johnson Company) holds marketing rights. In November 2011, Xarelto was also approved by the US Food and Drug Administration (FDA) to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF).
On December 19, Xarelto received further marketing approval in the EU for the prevention of stroke and systemic embolism in patients with Atrial Fibrillation as well as for the treatment of deep vein thrombosis (DVT) and the prevention of recurrent DVT and pulmonary embolism following an acute DVT in adult patients.
How Does Xarelto Work?
Xarelto is the first oral direct and highly selective inhibitor of Factor Xa, an enzyme which acts at a pivotal point in the blood-clotting (coagulation) process.
- Coagulation requires a complex series of chemical reactions and body signals. This process of chemical reactions is often referred to as the ‘Clotting Cascade’. One of the many clotting factors (blood clot proteins) is Factor Xa. Factor Xa is needed to produce thrombin that promotes the formation of blood clots. One molecule of Factor Xa catalyses the formation of approximately 1,000 thrombin molecules via what is known as a ‘thrombin burst’. 1, 2
- Directly targeting and inhibiting Factor Xa prevents the thrombin burst. Selectivity to Factor Xa has been proven to be clinically meaningful. Studies have demonstrated an increase in the anticoagulant efficacy of heparin-based drugs as their selectivity for Factor Xa increases. 1
What are the Benefits of Xarelto?
New oral anticoagulants hold the promise of overcoming the limitations of traditional anticoagulants, thereby enabling their use to prevent and or treat more venous and arterial thromboembolic conditions.
Benefits of Xarelto include oral administration, predictable anticoagulation without the need for routine coagulation monitoring or frequent dose adjustment, low risk of drug-drug interactions and no dietary restrictions.
Xarelto has demonstrated clinical benefit in comparison to standard therapy in a broad range of indications.
The Clinical Trial Programme for Xarelto
More than 75,000 patients have taken part in the Xarelto clinical development programme so far, evaluating the product in the prevention and treatment of a broad range of venous and arterial thromboembolic conditions, including:
- Prevention of venous thromboembolism (VTE) in adult patients undergoing total elective hip or knee replacement surgery
- Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE
- Prevention of stroke and systemic embolism in patients with atrial fibrillation (AF)
- Prevention of VTE in acutely ill, hospitalised patients
- Secondary prevention of acute coronary syndrome (ACS)
The extensive clinical trial programme supporting Xarelto makes it the most studied and widely published new oral anticoagulant in the world today.
- About ACS
- About Stroke Prevention in AF
- About Thrombosis
- About VTE
- About Xarelto
- ATLAS Clinical Study
- Clinical Trial Programme
- EINSTEIN Trial Programme
- Glossary of Terms
- History of Anticoagulants
- RECORD Trial Programme
- ROCKET AF Study
- 1 - Xarelto® (rivaroxaban) Summary of Product Characteristics as approved by the European Commission.
- 2 - Eriksson BI, Borris LC, Friedman RJ, et al; RECORD1 Study Group. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med. 2008;358(26):2765-2775.
- Venous thromboembolism
- A disease process beginning with a blood clot occurring within the venous system, including deep vein thrombosis and pulmonary embolism.
- Acute coronary syndrome
- An umbrella term used to cover any group of clinical symptoms compatible with an acute heart attack. The subtypes of acute coronary syndrome include unstable angina (in which the heart muscle is not damaged), and two forms of heart attack in which the heart muscle is damaged. These latter types are named according to the appearance of the electrocardiogram as non-ST segment elevation myocardial infarction (NSTEMI) and ST segment elevation myocardial infarction (STEMI).
- 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.
- The ability of a drug to produce the desired effect.
- Factor Xa
- Pivotal component of blood clotting cascade. Stimulates the production of thrombin, the enzyme in the coagulation cascade that promotes the formation of blood clots.
- Enzyme in the blood clotting cascade that promotes the formation of blood clots.
- Formation of a clot inside a blood vessel.
- 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.
Xarelto in Factor Xa Molecule
Image shows one molecule of Xarelto blocking the active site of a Factor Xa protein (generated from X-ray crystallography).
©2012, Bayer Pharma AG
Fragments of thrombi can break free to form potentially life-threatening pulmonary emboli.
Whole lung in which pulmonary arteries are obstructed by fresh (red) thrombus (circles).
Major veins of the lower extremity
Acute Coronary Syndrome (ACS)Bayer’s Xarelto (Rivaroxaban) Recommended for Approval in the EU for the Prevention of Atherothrombotic Events after an ACS
- Xarelto 2.5 mg twice-daily (BID) demonstrated significant clinical benefit for patients with ACS when used with standard antiplatelet therapy
- Complementary modes of action of Xarelto 2.5 mg BID and antiplatelet therapy have the potential to provide more complete protection against long-term clot formation
- Final decision from the European Commission expected in the first half of 2013
Low-dose rivaroxaban given fast track designation by U.S. FDA as first novel oral anticoagulant to be evaluated in this high-risk patient groupNew Pivotal Phase III Study Initiated with Bayer’s Xarelto (Rivaroxaban) in Patients with Chronic Heart Failure and Significant Coronary Artery Disease
62nd American College of Cardiology (ACC) Annual Scientific Session and Exposition:New Data on Bayer’s Rivaroxaban Underscores Clinical Benefits of Arterial Clot Prevention in Two Major Cardiovascular Disorders
- Benefits of rivaroxaban in acute coronary syndrome (ACS) highlighted in new subanalyses to be presented from Phase III ATLAS ACS 2-TIMI 51 study
- Subanalysis from ROCKET AF Phase III trial to be presented, further exploring the protective benefits of rivaroxaban in stroke prevention in patients with AF
- Independently, Thrombosis Research Institute (TRI) and Duke Clinical Research Institute to present data from their Registries in patients with AF, which are supported through independent research grants from Bayer and Janssen respectively
- Bayer and Janssen announce clinical collaboration agreement with Portola
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
- Blood clots obstructing blood flow in deep veins or in the lungs kill more than 2,300 people every day worldwide and urgent action is essential to save lives
- Rivaroxaban works as fast as injectable enoxaparin, providing efficacy when needed for as long as needed
- Rivaroxaban offers the only oral single-drug solution for the treatment of PE and longterm prevention of DVT and PE, without the need for injections or monitoring
- Rivaroxaban is approved to protect patients from blood clots across more venous and arterial thromboembolic diseases than any other novel oral anticoagulant
- 20,000-patient study will be conducted in collaboration with Population Health Research Institute
- Composite of cardiovascular death, myocardial infarction and stroke as primary efficacy endpoint
- Rivaroxaban is the first novel oral anticoagulant under assessment in this high risk patient population
- Multiple sub-analyses to be presented from the important Phase III ROCKET AF Study in patients with non-valvular Atrial Fibrillation (AF) and heart failure or diabetes
- Additional Phase III ATLAS ACS 2-TIMI 51 data analyses on rivaroxaban in secondary ACS prevention also to be presented
- Rivaroxaban offers the first oral single-drug solution for the treatment of PE and long-term prevention of DVT and PE
- Decision of European Commission on approval expected before year-end
- Supplemental New Drug Application for Rivaroxaban to reduce the risk of stent thrombosis in patients with Acute Coronary Syndrome also resubmitted
- Patients with STEMI are at high risk of recurrent cardiovascular (CV) events, including death
- Analysis of almost 8,000 STEMI patients confirms rivaroxaban to significantly reduce the composite primary efficacy endpoint of CV death, myocardial infarction, or stroke
- Rivaroxaban 2.5 mg twice daily significantly reduced CV death and all-cause death
- Data are consistent with results from the ATLAS ACS 2-TIMI 51 Phase III study which confirmed the effectiveness of rivaroxaban in secondary prevention after an ACS
- Important Phase III data from ATLAS ACS 2-TIMI 51 Study on secondary ACS prevention in higher risk, ST-Elevation Myocardial Infarction (STEMI) patients will be highlighted in a Clinical Trial and Registry Update Session
- Further sub-analyses from the successful 14,000 patient Phase III ROCKET AF Trial of rivaroxaban in patients with non-valvular Atrial Fibrillation (AF) will also be presented
- Independently, the Thrombosis Research Institute (TRI) will present data from the GARFIELD Registry, an academic research initiative, supported through an unrestricted educational grant from Bayer
- Positive NICE appraisal based on detailed analysis of the clinical and cost-effectiveness benefits of Xarelto
- NICE recommendation provides NHS patients with the only oral single-drug therapy for the initial treatment of DVT as well as the long-term prevention of DVT and PE
- Bayer also provides update on the U.S. filing of rivaroxaban in stent thrombosis
- U.S. FDA Issues Complete Response Letter for Bayer’s Xarelto (Rivaroxaban) for the Reduction of Secondary Cardiovascular Events in Patients with ACS
Secondary Prevention of Acute Coronary Syndrome (ACS)U.S. FDA Advisory Committee Recommends Against Approval of Bayer's Xarelto (Rivaroxaban) to Reduce the Risk of Secondary Cardiovascular Events in Patients with ACS
- Submissions for marketing authorization supported by the successful global EINSTEIN study program
- Rivaroxaban is the first oral single-drug solution proven effective for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE)
Prevention of Venous Blood Clots after Elective Total Hip or Knee Replacement Surgery:Real-World Experience Reaffirms Bayer’s Xarelto (Rivaroxaban) as Safe and Effective in Protecting Patients Against Blood Clots
- Outcomes from XAMOS study of more than 17,000 orthopaedic surgery patients provide further confirmation of clinical value of rivaroxaban
- XAMOS reaffirms robust findings from RECORD – the world’s largest trial programme assessing oral anticoagulation in people requiring hip or knee replacement
- Rivaroxaban is the world’s most prescribed new oral anticoagulant in the orthopaedic setting, with almost 2 million patients treated in this indication alone
- Submission based on the successful outcome of EINSTEIN-PE study
- Rivaroxaban offers the first oral single-drug solution for the initial treatment of PE and long-term prevention of DVT and PE
Stroke Prevention in Patients with Atrial Fibrillation:Bayer’s Xarelto Approved in Japan for Stroke Prevention in Patients with Non-Valvular Atrial Fibrillation
Acute Coronary Syndrome (ACS):Bayer’s Xarelto (Rivaroxaban) Submitted for EU Marketing Authorisation for Secondary Prevention after an Acute Coronary Syndrome
- Submission based on positive results of ATLAS ACS 2-TIMI 51 study
- Xarelto is the only new oral anticoagulant to demonstrate significant clinical benefit in this indication when used in combination with standard antiplatelet therapy
- In stroke prevention in AF, Xarelto is the only oral anticoagulant offering patients a once-daily, highly effective therapy without need for routine coagulation monitoring
- For the treatment of DVT and the prevention of recurrent DVT and PE, Xarelto is the first oral anticoagulant to offer patients both efficacy and the convenience of a single-drug solution, without the need for injections or monitoring
- Xarelto is now approved in the EU across three indications in the area of venous and arterial thromboembolism (VAT)
Secondary Prevention of Acute Coronary Syndrome (ACS):Bayer’s Xarelto (Rivaroxaban) Meets Primary Efficacy Endpoint and Shows Significant Reduction in Mortality in Major ACS Study
- Rivaroxaban Meets Primary Efficacy Endpoint, Significantly Reducing the Composite of Cardiovascular Death, Myocardial Infarction and Stroke
- Rivaroxaban 2.5 mg twice daily Significantly Reduced Both the Rate of Cardiovascular Death and the Incidence of All-Cause Mortality by more than 30%
- Major Bleeding in Patients Receiving Rivaroxaban was Significantly Increased but there was no Increase in the Risk of Fatal Bleeding
- Study Results Presented as a Late-Breaker at the Scientific Sessions of the American Heart Association and Published by the New England Journal of Medicine
Stroke Prevention in Patients with Atrial Fibrillation:US FDA Approves Bayer’s Xarelto (Rivaroxaban) to Reduce the Risk of Stroke and Systemic Embolism in Patients with Non-Valvular Atrial Fibrillation
- Rivaroxaban is highly effective and well tolerated in protecting patients with Atrial Fibrillation from stroke
- Rivaroxaban is the only anticoagulant with once-daily fixed dosing for stroke prevention in patients with atrial fibrillation
- Rivaroxaban does not require routine coagulation monitoring, making it more convenient to both patients and physicians
- CHMP recommends approval of rivaroxaban for two new chronic indications
- Upon approval, rivaroxaban would be the only new oral anticoagulant approved in three indications in all EU member states
- Decision of European Commisson on approval expected in fourth quarter 2011
Stroke Prevention in Patients with Atrial Fibrillation:U.S. FDA Advisory Committee Recommends Approval of Bayer’s Xarelto (Rivaroxaban)
- Xarelto is the only new oral anticoagulant with US approval in this indication
Stroke Prevention in Patients with Atrial Fibrillation:Bayer’s Rivaroxaban Submitted for Approval in Japan
Prevention of VTE in hospitalized, acutely ill patientsIn the Prevention of VTE in Acutely ill Patients, Rivaroxaban Compares Favorably with Enoxaparin but Does Not Show a Consistent Net Clinical Benefit
- MAGELLAN study meets primary efficacy endpoints of demonstrating non-inferiority in short-term use and superiority in long-term use
- Primary analysis shows no consistent positive benefit-risk balance across heterogeneous patient population studied
- Submission in Stroke Prevention in Patients with Atrial Fibrillation (AF) based on positive results of ROCKET AF trial in more than 14,000 patients
- Submission in Treatment of DVT and Prevention of Recurrent DVT and PE based on positive results of EINSTEIN-DVT and EINSTEIN-Extension clinical studies in more than 4,500 patients
Treatment of Deep Vein Thrombosis:Bayer´s Rivaroxaban Successfully Meets Primary Efficacy Outcome and Demonstrates Similar Safety to Standard Therapy in Phase III EINSTEIN-DVT Non-Inferiority Study
- Results from EINSTEIN-DVT Study Presented at European Society of Cardiology Congress 2010
- Rivaroxaban shows superiority to standard therapy in net clinical benefit, a secondary endpoint of the study
- Rivaroxaban well tolerated in this long-term trial
- Full data set to be presented at Hot Line Session at ESC 2010
Treatment of Venous Thromboembolism (VTE):Phase III EINSTEIN-Extension Study of Bayer’s Rivaroxaban Shows Significant Benefit in the Prevention of Secondary Symptomatic VTE
- Impressive 82% Relative Risk Reduction (RRR) in the Recurrence of Symptomatic VTE over Patients Treated with Placebo
- Positive Benefit-Risk profile for Rivaroxaban Confirmed
- First Phase III Data in the Chronic Setting to be Presented as a Late-Breaker at the Annual Meeting of the American Society of Hematology
- Ongoing Discussions with FDA on Complete Response Letter for VTE Prevention After Total Knee and Hip Replacement Surgery
Leading-edge research in science and medicine:Bayer Team wins the “Deutscher Zukunftspreis” awarded by the German President
- German Federal President Horst Köhler praises outstanding innovation achievement
- Development of the novel oral anticoagulant rivaroxaban commended
Positive Results from Chronic Study with Bayer’s Rivaroxaban Will be Presented As a Late Breaker at ASH 2009Positive Results from Chronic Study with Bayer’s Rivaroxaban Will be Presented As a Late Breaker at ASH 2009
Leading-edge medical research and development:Bayer researchers nominated for the “Deutscher Zukunftspreis” awarded by the German Federal President
- Development of the novel anticoagulant rivaroxaban commended
- Three research and development teams on shortlist
Bayer Committed to Prevention of Arterial Thrombosis:Bayer Completes Enrollment into Major Phase III Study with Rivaroxaban (ROCKET AF)
- ROCKET AF study compares rivaroxaban to warfarin in the prevention of stroke and non-CNS systemic embolism in patients with Atrial Fibrillation
- Bayer Schering Pharma supports Thrombosis Research Institute’s launch of GARFIELD – a global patient Registry to evaluate ‘real life’ outcomes in the prevention of stroke in patients with Atrial Fib
- Fast Track designation for rivaroxaban development program in the secondary prevention of cardiovascular events in patients with Acute Coronary Syndrome recognizes high unmet medical need.
New Drug Application for Rivaroxaban in the U.S.:Update on Status of Rivaroxaban Complete Response Letter From U.S. FDA
Venous Blood Clot Prevention after Hip or Knee Replacement Surgery:U.S. FDA Issues Complete Response Letter for Rivaroxaban
- No new clinical or non-clinical studies to be conducted as a pre-requisite for approval
Venous Blood Clot Prevention after Hip or Knee Replacement Surgery:U.S. FDA Advisory Committee supports favorable benefit-risk profile of Bayer’s rivaroxaban
Venous Blood Clot Prevention after Knee or Hip Replacement Surgery:Xarelto Reduces Symptomatic VTE and Death Following Knee or Hip Replacement Surgery by More Than 50% Compared to Enoxaparin in Pooled Analysis of RECORD Clinical Trial Program
- Pooled Analysis of RECORD1-4 Trials Confirms Significant Benefit in Clinical Outcomes for Patients Treated with Xarelto
- RECORD4 Study Demonstrates Xarelto is the Only Oral Anticoagulant to Show Clinical Benefit in Head-to-Head Comparison Against U.S.-Approved Regimen of Enoxaparin
Secondary Prevention in Acute Coronary Syndrome (ACS):Bayer’s Xarelto Shows Encouraging Results in Patients with Acute Coronary Syndrome
- Phase II Data Presented as Late-Breaker at American Heart Association Meeting
- Phase III Study to be Initiated in December 2008
Venous Blood Clot Prevention after Elective Hip or Knee Replacement Surgery:Bayer’s Novel Anticoagulant Xarelto now also Approved in the EU
- Bayer will start marketing the new oral, once-daily anticoagulant very soon
- First-in-class product to demonstrate superior efficacy to current standard of care
Venous Blood Clot Prevention after Elective Total Knee and Hip Replacement Surgery:Bayer’s Xarelto Approved in Canada
- First approval for Bayer's new oral, once-daily anticoagulant
- Marketing to start immediately
- First-in-class product to demonstrate superior efficacy to standard of care
- Most studied oral, direct Factor Xa inhibitor in the world today
Secondary prevention in acute coronary syndrome (ACS):Rivaroxaban Phase II Data in ACS to be Presented at AHA Congress in November 2008
- First data presentation from large dose-finding trial involving about 3,500 patients
- Acceleration of clinical development in acute coronary syndrome planned
Venous Blood Clot Prevention after Hip or Knee Replacement Surgery:Bayer’s Novel Anticoagulant Rivaroxaban Submitted for Approval in the U.S.
- Rivaroxaban is first oral anticoagulant to achieve superior efficacy over the twice-daily
- No evidence of safety issues attributable to rivaroxaban after long-term exposure
Venous Blood Clot Prevention after Elective Hip or Knee Replacement Surgery:Bayer’s Novel Anticoagulant Rivaroxaban Recommended for Approval in the EU
- Final approval from the European Commission expected within the next few months
Venous Blood Clot Prevention after Knee and Hip Replacement Surgery:Rivaroxaban is First Novel Oral Anticoagulant to Significantly Reduce the Composite Outcome of Symptomatic VTE and Death
- Rivaroxaban shows superior efficacy to enoxaparin for this clinical outcome with a
- Pre-specified analysis of pooled data from RECORD 1-3 studies involving nearly
Venous Blood Clot Prevention after Total Hip and Knee Replacement Surgery:New England Journal of Medicine Publishes Results from Two of the Landmark Phase III RECORD Studies with Rivaroxaban
- Head-to-Head trials involving over 7000 patients after Major Orthopedic Surgery
- Rivaroxaban superior to Enoxaparin in Preventing Venous Blood Clots
- Bleeding rates were low and comparable between the treatment arms
Venous Blood Clot Prevention after Hip Replacement Surgery:The Lancet Publishes Results from the Landmark Phase III Rivaroxaban Study RECORD2
- Trial involving over 2.500 patients after hip replacement surgery
- Five weeks of Rivaroxaban compared to two weeks enoxaparin
- Extended Rivaroxaban treatment regimen significantly more effective with comparable low bleeding rates
Prevention of Thromboembolism after Knee Replacement Surgery:Rivaroxaban One Tablet/Once-Daily Superior to Twice-Daily Injectable Enoxaparin in Preventing Venous Blood Clots after Total Knee Replacement Surgery in Pivotal Phase III Trial
- Rivaroxaban is First Oral Anticoagulant to Achieve Superior Efficacy over the Twice- Daily Injection of Enoxaparin while Maintaining Low Major Bleeding Rates
- RECORD4 Confirms Results of RECORD1, 2 and 3
- U.S. Submission Planned for mid 2008
- Prof. Turpie: “Rivaroxaban has the potential to revolutionize the way we prevent the formation of dangerous blood clots”
VTE Prevention After Major Orthopaedic Surgery:Three Pivotal Phase III Trials Show Superior Efficacy of Rivaroxaban over Standard of Care with Enoxaparin
- Consistent results across three RECORD trials involving nearly 10,000 patients
- Venous thromboembolism considered the most frequent and potentially fatal complication following major orthopaedic surgery
- No evidence of liver signal attributable to rivaroxaban has been seen
VTE Prevention After Hip Replacement Surgery:Pivotal Phase III Data Show Superior Efficacy of Rivaroxaban over Enoxaparin
- Head-to-Head Study Demonstrates Similar and Low Rate of Bleeding for Both Drugs
- Endpoints Met for RECORD1 and RECORD2 Trials in Total Hip Replacement Surgery
Prevention of Venous Thromboembolism after Major Orthopedic Surgery:Bayer HealthCare Submits Rivaroxaban for European Approval
- Data Package for Rivaroxaban Involves Nearly 10,000 Patients in Three Phase III Trials