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®.

About 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.







  • 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.
Efficacy
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.
Thrombin
Enzyme in the blood clotting cascade that promotes the formation of blood clots.
Thrombosis
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.

Images

Xarelto in Factor Xa Molecule

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).

www.xarelto.com
©2008, Bayer Schering Pharma AG



Propagation

Propagation

Activated Factor X, functioning as part of the prothrombinase complex on the surface of activated platelets, converts large amounts of prothrombin to thrombin, in the “thrombin burst.”





Embolus formation

Embolus formation

Fragments of thrombi can break free to form potentially life-threatening pulmonary emboli.






Pulmonary embolus

Pulmonary embolus

Whole lung in which pulmonary arteries are obstructed by fresh (red) thrombus (circles).






Pulmonary embolism

Pulmonary embolism

The pathway of a pulmonary embolism (PE) from the lower half of the body: inferior vena cava, to right atrium, to right ventricle, to the pulmonary artery. This eventually obstructs blood flow to the lung. Patients with deep vein thrombosis (DVT) are at risk of PE, a life-threatening event.



Major veins of the lower extremity

Major veins of the lower extremity

The most common type of VTE is deep vein thrombosis (DVT), which occurs in veins deep within the muscles of the leg and pelvis.










Press Releases

9th May 2012

Not intended for U.S. and UK media

Bayer’s Xarelto® (Rivaroxaban) Submitted to U.S. FDA to Reduce the Risk of Stent Thrombosis in Patients with Acute Coronary Syndrome
2nd May 2012

Not intended for U.S. and UK media

Bayer’s Xarelto® (Rivaroxaban) Submitted to U.S. FDA for the Treatment of Venous Thromboembolism (VTE) and Long-Term Prevention of Recurrent VTE
  • 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)
17th April 2012

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
April 12, 2012

Not intended for U.S. and UK media

Bayer’s Xarelto® (Rivaroxaban) Submitted for EU Marketing Authorisation for the Treatment of Pulmonary Embolism (PE) and Prevention of Recurrent Deep Vein Thrombosis (DVT) and PE
  • 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
26th Mar 2012

Not intended for U.S. and UK Media - Treatment of Pulmonary Embolism (PE)

Bayer's Xarelto® (Rivaroxaban) Proven Effective in Treating Patients with Pulmonary Embolism and in Preventing Recurrent Venous Blood Clots in Phase III EINSTEIN-PE Study
  • Rivaroxaban as effective as current standard of care in treatment of pulmonary embolism and secondary prevention of venous blood clots
  • Patients receiving rivaroxaban showed significantly reduced major bleedings compared to current standard of care
  • Rivaroxaban offers the first oral single-drug solution for the initial treatment and long-term prevention of pulmonary embolism
  • Study results presented as a Late-Breaker at the American College of Cardiology Annual Scientific Sessions and published in the New England Journal of Medicine
19 Mar 2012

Not intended for UK and US Media - Treatment of Pulmonary Embolism (PE)

Results of the Phase III EINSTEIN-PE Study with Bayer’s Xarelto® (Rivaroxaban) to be Presented in Late-Breaking Clinical Trials Session at ACC 2012
28th Feb 2012

Not intended for U.S. and UK Media

Bayer’s Xarelto® (Rivaroxaban) Granted Priority Review by US FDA to Prevent Secondary Cardiovascular Events in Patients with ACS
18th Jan 2012

Not intended for UK and US Media - Stroke Prevention in Patients with Atrial Fibrillation:

Bayer’s Xarelto® Approved in Japan for Stroke Prevention in Patients with Non-Valvular Atrial Fibrillation
29nd Dec 2011

Not intended for U.S. and UK Media - Submission in New Indication:

Bayer’s Xarelto® (Rivaroxaban) Submitted for U.S. Marketing Authorisation to Reduce Secondary Cardiovascular Events in Patients with Acute Coronary Syndrome
22nd Dec 2011

Not intended for U.S. and UK media: 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
19th Dec 2011

For use outside the US and UK only

Bayer’s Xarelto® Approved in the EU for the Prevention of Stroke in Patients with AF and in the Treatment of DVT
  • 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)
13th Nov 2011

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
4th Nov 2011

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
23rd Sept 2011

Not intended for U.S. and UK media

Xarelto® Recommended for Approval in the Prevention of AF Related Stroke and Treatment of Deep Vein Thrombosis in EU
  • 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
9th Sept 2011

Stroke Prevention in Patients with Atrial Fibrillation:

U.S. FDA Advisory Committee Recommends Approval of Bayer’s Xarelto® (Rivaroxaban)
1st July 2011

FDA Approves Xarelto® (rivaroxaban tablets) for the Prophylaxis of Deep Vein Thrombosis Which May Lead to a Pulmonary Embolism in Patients Undergoing Knee or Hip Replacement Surgery
  • Xarelto® is the only new oral anticoagulant with US approval in this indication
14th Apr 2011

Stroke Prevention in Patients with Atrial Fibrillation:

Bayer’s Rivaroxaban Submitted for Approval in Japan
5th Apr 2011

Prevention of VTE in hospitalized, acutely ill patients

In 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
5th Jan 2011

For use outside the U.S. only

Bayer’s Rivaroxaban Submitted for EU Marketing Authorisation in Stroke Prevention in Patients with Atrial Fibrillation as well as for the Treatment of Deep Vein Thrombosis (DVT) and Prevention of Recurrent DVT and Pulmonary Embolism (PE)
  • 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
5th Jan 2011

For use outside the U.S. only

Bayer’s Rivaroxaban Submitted for Marketing Authorisation in Stroke Prevention in Patients with Atrial Fibrillation in the US
31st Aug 2010

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
4th Aug 2010

Bayer’s Rivaroxaban Meets Primary Endpoint in Long-Term Phase III EINSTEIN-DVT Study
  • 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
17th Jun 2010

Results from Phase III EINSTEIN-DVT Study with Bayer’s Rivaroxaban to be Presented at Hot Line Session at ESC 2010
6th Dec 2009

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
2nd Dec 2009

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
19th Nov 2009

Positive Results from Chronic Study with Bayer’s Rivaroxaban Will be Presented As a Late Breaker at ASH 2009

Positive Results from Chronic Study with Bayer’s Rivaroxaban Will be Presented As a Late Breaker at ASH 2009
22nd Sep 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
30th Aug 2009

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.
14th July 2009

New Drug Application for Rivaroxaban in the U.S.:

Update on Status of Rivaroxaban Complete Response Letter From U.S. FDA
28th May 2009

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
19th Mar 2009

Venous Blood Clot Prevention after Hip or Knee Replacement Surgery:

U.S. FDA Advisory Committee supports favorable benefit-risk profile of Bayer’s rivaroxaban
08. Dec 2008

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
10. Nov 2008

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
01. Oct 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
16 Sept 2008

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
31 Aug 2008

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
30 Jul 2008

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
25 Jul 2008

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
30 Jun 2008

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
26. Jun 2008

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
25. Jun 2008

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
30. May 2008

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”
10. Dec 2007

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
8. Dec 2007

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
9. Nov 2007

New Phase III Trial Results for Rivaroxaban to be Presented at the 49th Annual Meeting of the American Society of Hematology
  • Endpoints Met for RECORD1 and RECORD2 Trials in Total Hip Replacement Surgery
31. Oct 2007

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

Contact

Stephanie Prate

Global Pharma Product PR Corporate Communications &
Public Affairs

Address:

Bayer Pharma AG
Germany-13353 Berlin

Telephone: +49 30 468 196053
Telefax: +49 30 468 996053

E-Mail Stephanie Prate

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The overall Xarelto® study programme is planned to include about 50,000 patients. To date, rivaroxaban is the most studied oral direct Factor Xa inhibitor in development. 9

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