Xarelto News
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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).
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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.
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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.
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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
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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
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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 -
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.
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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.
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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
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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).
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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
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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
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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).
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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
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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
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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.
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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
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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
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Positive Results from Chronic Study with Bayer’s Rivaroxaban Will be Presented As a Late Breaker at ASH 2009
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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
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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.
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New Drug Application for Rivaroxaban in the U.S.: Update on Status of Rivaroxaban Complete Response Letter From U.S. FDA
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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
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U.S. FDA Advisory Committee supports favorable benefit-risk profile of Bayer’s rivaroxaban
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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
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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
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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.
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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
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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
