Xarelto News

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

This website is intended to provide information to an international audience outside the USA and UK.

Xarelto News

This website is intended to provide information to an
international audience outside the USA and UK.