Rivaroxaban Virtual Media Kit
The past decade has witnessed a growth of research into oral, direct Factor Xa inhibitors, and several are now in clinical development. Rivaroxaban is an investigational, oral, direct Factor Xa inhibitor being developed jointly by Johnson & Johnson Pharmaceutical Research & Development, LLC (J&J PRD) and Bayer HealthCare AG. Rivaroxaban is currently being evaluated by the U.S. Food & Drug Administration (U.S. FDA) for the prevention and treatment of a broad range of disorders in which blood clotting plays a major role.
The extensive program of clinical trials evaluating rivaroxaban makes rivaroxaban the most studied oral, direct Factor Xa inhibitor in the world today. More than 65,000 patients are expected to enroll in the rivaroxaban clinical development Phase 3 program, which includes the following trials:
- RECORD: VTE prevention in patients undergoing total hip and total knee replacement
- EINSTEIN: VTE treatment and secondary prevention
- ROCKET AF: Stroke prevention in patients with atrial fibrillation
- MAGELLAN: VTE prevention in medical, (non-surgical) patients
- ATLAS ACS TIMI 51: Secondary prevention of acute coronary syndrome
- (March 26, 2012)XARELTO® (rivaroxaban) Demonstrates Comparable Efficacy to Standard of Care for the Treatment and Secondary Prevention of Venous Blood Clots in Patients with Symptomatic Pulmonary Embolism in Pivotal Phase 3 Study
- (February 27, 2012) U.S FDA Grants Priority Review for XARELTO® (rivaroxaban) to Reduce Secondary Cardiovascular Events in Patients with Acute Coronary Syndrome
- (December 29, 2011) Janssen Research & Development Submits Application to U.S. FDA for XARELTO® (rivaroxaban)to Reduce Secondary Cardiovascular Events in Patients with Acute Coronary Syndrome
- (November 13, 2011) Landmark Study Shows that Adding Rivaroxaban to Standard Antiplatelet Therapy Significantly Reduced Secondary Cardiovascular Events in Patients with Acute Coronary Syndrome
- (November 4, 2011) FDA Approves XARELTO® (rivaroxaban) to Reduce the Risk of Stroke and Systemic Embolism in Patients with Nonvalvular Atrial Fibrillation
- (September 8, 2011) FDA Advisory Committee Recommends Approval of Oral Anticoagulant Rivaroxaban for the Prevention of Stroke and Systemic Embolism in Patients with Non-Valvular Atrial Fibrillation
- (July 1, 2011) FDA Approves XARELTO® (rivaroxaban tablets) to Help Prevent Deep Vein Thrombosis in Patients Undergoing Knee or Hip Replacement Surgery
- (April 5, 2011)In Study of Acutely Ill Patients Rivaroxaban Compares Favorably With Enoxaparin in Preventing Venous Thromboembolism but With an Increased Rate of Bleeding.
- (January 5, 2011) New Drug Application Submitted to FDA for Rivaroxaban for Prevention of Stroke in Patients with Atrial Fibrillation
- (November 15, 2010) Rivaroxaban Significantly Reduces Risk of Stroke in Patients with Atrial Fibrillation with Comparable Safety vs. Warfarin in Pivotal Phase 3 Study
- (August 31, 2010) Rivaroxaban Successfully Demonstrated Non-Inferiority Compared to Standard of Care for the Prevention of Recurrent Venous Thromboembolism in Pivotal Phase 3 Study
- (December 6, 2009) Phase III Study of Rivaroxaban Shows That Extending Anticoagulant Treatment by Six or 12 Months Significantly Reduced Risk of Second Symptomatic VTE
- (May 28, 2009) FDA Issues Complete Response Letter for Rivaroxaban
- (March 19, 2009) FDA Advisory Committee Finds Favorable Risk-Benefit Profile for Oral Anticoagulant Rivaroxaban for Prophylaxis of Deep Vein Thrombosis and Pulmonary Embolism after Hip or Knee Replacement Surgery
- (December 7, 2008) Rivaroxaban Reduces Symptomatic VTE & Death Following Knee or Hip Replacement Surgery by More Than 50% Compared to Enoxaparin in Pooled Analysis of the RECORD Clinical Trial Program
- (November 10, 2008) Rivaroxaban Phase II Dose-Ranging Study Demonstrates Encouraging Response Rates in Treatment of Acute Coronary Syndrome Patients
- (May 30, 2008) Rivaroxaban Demonstrates Significant Reduction in Venous Thromboembolism after Total Knee Replacement Surgery Compared to the U.S.-Approved Dosing Regimen for Enoxaparin in Pivotal Phase III Trial
- (July 30, 2008) Johnson & Johnson Pharmaceutical Research & Development, LLC Submits New Drug Application to FDA for Rivaroxaban
- (December 8, 2007) Pivotal Phase III Data Showed Rivaroxaban Was Statistically Superior to Enoxaparin in Preventing Venous Thromboembolism (VTE) in Patients Following Hip Replacement Surgery
- (December 10, 2007) Three Phase III Trials Show Rivaroxaban Outperformed Enoxaparin in Preventing Venous Thromboembolism After Major Orthopedic Surgery
About Arterial Blood Clots
About Venous Blood Clots
- Understanding Medically Ill and VTE
- Understanding Venous Blood Clots in Major Orthopedic Surgery
- Understanding Venous Thromboembolism
- Anticoagulant Therapy in the Treatment of Venous Blood Clots
- Clot in the Heart: When the heart's rhythm is disrupted by atrial fibrillation, a clot can form in the left atrium and travel to the brain, causing an embolic stroke.
- Heart/Head Path: A clot formed as a result of fibrillation can leave the heart and follow a direct path to the brain's arteries, causing an embolic stroke.
- An Embolic Stroke: A blood clot formed in the heart can travel to the brain and lodge in one of the brain's arteries, causing an embolic stroke.