Xarelto News

22nd March 2013
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
8th March 2013
New Pivotal Phase III Study Initiated with Bayer’s Xarelto (Rivaroxaban) in Patients with Chronic Heart Failure and Significant Coronary Artery Disease
Bayer HealthCare and its cooperation partner Janssen Research & Development, LLC announced today the initiation of COMMANDERHF, a pivotal Phase III clinical trial that will evaluate Xarelto (rivaroxaban) 2.5 mg twice daily in patients with chronic heart failure (HF) and significant coronary artery disease (CAD). Rivaroxaban is the first novel oral anticoagulant to be evaluated in this patient group who remain at high-risk for complications following hospitalization for exacerbation of their HF.
8th March 2013
Bayer Initiates Xarelto (Rivaroxaban) Study in Patients with Non- Valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention with Stent Placement
Bayer HealthCare announced today the initiation of the PIONEER AF-PCI study, a Phase IIIb clinical study of its oral anticoagulant Xarelto (rivaroxaban) to investigate how best to treat patients with non-valvular atrial fibrillation (AF) who undergo percutaneous coronary intervention (PCI) with stent placement.
5th March 2013
U.S. FDA Issues Complete Response Letter for Bayer’s Xarelto (Rivaroxaban) for the Reduction of Cardiovascular Events in Patients with ACS
Bayer HealthCare announced today that the U.S. Food and Drug Administration (FDA) issued a second complete response letter regarding the supplemental New Drug Application (sNDA) for the oral anticoagulant Xarelto(rivaroxaban) 2.5 mg BID in combination with standard antiplatelet therapy for the reduction of cardiovascular events (cardiovascular death, myocardial infarction or stroke) in patients with Acute Coronary Syndrome (ACS). Bayer is evaluating the complete response letter from the FDA together with its cooperation partner Janssen Research & Development, LLC, and will respond to the Agency’s questions.
1st March 2013
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
5th February 2013
Xarelto to be Studied with Factor Xa Inhibitor Antidote
Bayer and Janssen announce clinical collaboration agreement with Portola.
30th November 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
- New data also show reduced hospital stay and improved patient-reported satisfaction with rivaroxaban for patients with acute symptomatic PE
20th November 2012
Bayer’s Xarelto (Rivaroxaban) Approved for the Treatment of Pulmonary Embolism (PE) and the Prevention of Recurrent Deep Vein Thrombosis (DVT) and PE in the EU
- 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
13th November 2012
Landmark Phase III Study of Bayer’s Xarelto (Rivaroxaban)
- 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
2nd November 2012
U.S. FDA Approves Xarelto (Rivaroxaban) to Treat Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE) as well as to Reduce the Risk of Recurrent Events
Rivaroxaban is the only oral single-drug solution proven effective for the treatment of DVT and PE
26th October 2012
Latest Xarelto (Rivaroxaban) Data to be Presented at AHA 2012
- 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
19th October 2012
Bayer’s Xarelto (Rivaroxaban) Recommended for EU Approval for the Treatment of Pulmonary Embolism (PE) and Prevention of Recurrent Deep Vein Thrombosis (DVT) and PE
- 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
7th September 2012
Complete Response Submitted to U.S. FDA on Bayer’s Rivaroxaban for the Reduction of Secondary Cardiovascular Events in Patients with Acute Coronary Syndrome
Supplemental New Drug Application for Rivaroxaban to reduce the risk of stent thrombosis in patients with Acute Coronary Syndrome also resubmitted
27th August 2012
Major Subgroup Analysis Shows Bayer’s Rivaroxaban To Significantly Reduce Mortality in Patients with ST-Segment Elevation Myocardial Infarction (STEMI)
- 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
20th August 2012
Latest Xarelto (Rivaroxaban) Data to be Presented at ESC Congress 2012
- 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
25th July 2012
UK’s NICE recommends Bayer’s Xarelto (Rivaroxaban), the Only Oral Single-Drug Therapy for the Treatment of Deep Vein Thrombosis (DVT) and Prevention of Recurrent DVT and Pulmonary Embolism (PE)
- 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
9th July 2012
Bayer’s Xarelto (Rivaroxaban) Granted Priority Review by U.S. FDA for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism and the Long-Term Prevention of Recurrent Venous Thromboembolism
Bayer also provides update on the U.S. filing of rivaroxaban in stent thrombosis
21th June 2012
Secondary Prevention of Acute Coronary Syndrome (ACS)
U.S. FDA Issues Complete Response Letter for Bayer’s Xarelto (Rivaroxaban) for the Reduction of Secondary Cardiovascular Events in Patients with ACS
23rd May 2012
UK's NICE recommends Bayer's Xarelto (Rivaroxaban) for the Prevention of Stroke in Patients with Non-Valvular Atrial Fibrillation
Bayer HealthCare's once-daily oral anticoagulant Xarelto (rivaroxaban) has today been recommended for National Health Service (NHS) use in final guidance from the National Institute for Health and Clinical Excellence (NICE) for the prevention of stroke and non-CNS systemic embolism in eligible adult patients with non-valvular atrial fibrillation (AF).
23rd May 2012
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
Bayer HealthCare announced today that the U.S. Food and Drug Administration's (FDA's) Cardiovascular and Renal Drugs Advisory Committee voted against the approval of the oral anticoagulant Xarelto (rivaroxaban) 2.5 mg BID in combination with standard antiplatelet therapy to reduce the risk of secondary cardiovascular events in patients with Acute Coronary Syndrome (ACS).
10th May 2012
Bayer's Xarelto (Rivaroxaban) Submitted to U.S. FDA to Reduce the Risk of Stent Thrombosis in Patients with Acute Coronary Syndrome
Bayer's cooperation partner, Janssen Research & Development, LLC has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the use of the oral anticoagulant Xarelto (rivaroxaban) 2.5 mg BID in combination with standard antiplatelet therapy to reduce the risk of stent thrombosis in patients with Acute Coronary Syndrome (ACS). An application for marketing authorization to reduce the risk of secondary cardiovascular events in patients with ACS has been filed with the U.S. FDA in December and is currently under review.
2nd May 2012
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
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
12th April 2012
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
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
19th Mar 2012
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
Bayer HealthCare announced today that findings from the Phase III EINSTEIN-PE study, with almost 5,000 patients, will be presented in the Late-Breaking Clinical Trials Session on Monday, March 26th, 2012, 08:00 – 09:30am CDT, at the American College of Cardiology's 61st Annual Scientific Sessions (ACC) in Chicago, USA, by lead investigator Harry R. Buller, MD, Academic Medical Center, Amsterdam, the Netherlands.
28th Feb 2012
Bayer's Xarelto (Rivaroxaban) Granted Priority Review by US FDA to Prevent Secondary Cardiovascular Events in Patients with ACS
Bayer, together with its cooperation partner, Janssen Research & Development, L.L.C., announced today that the US Food and Drug Administration (FDA) has granted Priority Review designation to the supplemental New Drug Application (sNDA) filed on December 29, 2011 for the oral anticoagulant Xarelto (rivaroxaban) in combination with standard antiplatelet therapy to reduce the risk of (thrombotic) cardiovascular events in patients with Acute Coronary Syndrome (ACS).
19th January 2012
Bayer's Xarelto Approved in Japan for Stroke Prevention in Patients with Non-Valvular Atrial Fibrillation
Bayer's once-daily oral anticoagulant Xarelto (rivaroxaban) has been approved for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation by the Japanese Ministry of Health, Labor and Welfare (MHLW).
29nd December 2011
Bayer's Xarelto (Rivaroxaban) Submitted for U.S. Marketing Authorisation to Reduce Secondary Cardiovascular Events in Patients with Acute Coronary Syndrome
Bayer's cooperation partner, Janssen Research & Development, L.L.C. has submitted a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for the oral anticoagulant Xarelto (rivaroxaban) in combination with standard antiplatelet therapy to reduce the risk of (thrombotic) cardiovascular events in patients with Acute Coronary Syndrome (ACS). The U.S. FDA has previously granted rivaroxaban “fast track” designation, given the seriousness of ACS and the potential clinical benefit of rivaroxaban.
22nd December 2011
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 December 2011
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
13th November 2011
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
4th November 2011
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 September 2011
Xarelto Recommended for Approval in the Prevention of AF Related Stroke and Treatment of Deep Vein Thrombosis in EU
Bayer HealthCare's oral anticoagulant Xarelto (rivaroxaban) has been recommended for approval by the European Committee for Medicinal Products for Human Use (CHMP) for both the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF), as well as for the treatment of deep vein thrombosis (DVT) and prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT in adults.
9th September 2011
U.S. FDA Advisory Committee Recommends Approval of Bayer's Xarelto (Rivaroxaban)
Bayer HealthCare announced today that the U.S. Food and Drug Administration's (FDA's) Cardiovascular and Renal Drugs Advisory Committee recommended approval of rivaroxaban (Xarelto) for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF) in the U.S. The committee voted 9-2 (with one abstention) in favor of approving rivaroxaban in this indication. A decision by the FDA is expected in early November 2011.
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 April 2011
Bayer's Rivaroxaban Submitted for Approval in Japan
Bayer's rivaroxaban (Xarelto) has been submitted for marketing approval in the prevention of stroke in patients with atrial fibrillation to the Japanese Ministry of Health, Labor and Welfare (MHLW).
5th April 2011
In the Prevention of VTE in Acutely ill Patients, Rivaroxaban Compares Favorably with Enoxaparin but Does Not Show a Consistent Net Clinical Benefit
Prevention of VTE in hospitalized, acutely ill patients
5th January 2011
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
5th January 2011
Bayer's Rivaroxaban Submitted for Marketing Authorisation in Stroke Prevention in Patients with Atrial Fibrillation in the US
Bayer's cooperation partner Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for the oral anticoagulant rivaroxaban for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF).
31st August 2010
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 August 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 June 2010
Results from Phase III EINSTEIN-DVT Study with Bayer's Rivaroxaban to be Presented at Hot Line Session at ESC 2010
Bayer Schering Pharma, Germany, today announced that findings from the Phase III EINSTEIN-DVT study will be presented at the Hot Line Session on August 31, 2010, 11:00-12:30 CET, at the Annual Meeting of the European Society of Cardiology (ESC) in Stockholm, Sweden, by lead investigator Harry R. Buller, MD, Academic Medical Center, Amsterdam, the Netherlands.
6th Dec 2009
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
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 November 2009
Positive Results from Chronic Study with Bayer's Rivaroxaban Will be Presented As a Late Breaker at ASH 2009
22nd September 2009
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 August 2009
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 Fibrillation
- 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 March 2009
U.S. FDA Advisory Committee supports favorable benefit-risk profile of Bayer's rivaroxaban
8th December 2008
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 Confirm 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
10th November 2008
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
7th November 2008
rivaroxaban 10mg film-coated tablets (Xarelto)
- The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHS Scotland.
1st October 2008
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
28th August 2008
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