Reduced-dosed Rivaroxaban and Standard-dosed Rivaroxaban Versus ASA in the Long-term Prevention of Recurrent Symptomatic Venous Thromboembolism in Patients With Symptomatic Deep-vein Thrombosis and/or Pulmonary Embolism
Phase of Trial: Phase III
Latest Information Update: 15 Sep 2017
At a glance
- Drugs Rivaroxaban (Primary) ; Aspirin
- Indications Deep vein thrombosis; Pulmonary embolism; Venous thromboembolism; Venous thrombosis
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms EINSTEIN-CHOICE
- Sponsors Bayer
- 15 Sep 2017 Based on the data from this trial, the CHMP of the EMA has granted a positive opinion to update the label for its oral Factor Xa inhibitor Xarelto (rivaroxaban) to include a 10 mg once daily dose for the extended prevention of recurrent venous thromboembolism (VTE) and the label update will apply to patients who have already received at least six months of standard anticoagulation therapy, as reported in a Bayer media release. The final European Commission decision is expected by November 2017.
- 28 Jun 2017 According to a Janssen media release, the U.S. Food and Drug Administration (FDA) accepted for Priority Review a supplemental New Drug Application (sNDA) for XARELTO (rivaroxaban) to include a 10 mg once-daily dose for reducing the risk of VTE after at least six months of standard anticoagulant therapy. Data from this study supported the application. The FDA's Prescription Drug User Fee Act (PDUFA) target date is October 28, 2017.
- 28 Apr 2017 According to a Janssen Research & Development media release, baesd on data from this trial, company has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) to update the prescribing information for XARELTO (rivaroxaban) to add a 10 mg dose to reduce patients risk of recurrent venous thromboembolism (VTE) after at least six months of standard anticoagulation therapy.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History