Rivaroxaban approved for long term VTE Protection by FDA

Rivaroxaban in a dose of 10 mg once daily has been cleared by the US Food and Drug Administration (FDA) for combating the ongoing risk of recurrent venous thromboembolism (VTE) following at least 6 months of initial anticoagulation therapy.

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Rivaroxaban is a factor Xa inhibitor which has already been approved for five indications across seven distinct areas of use, protecting patients across more venous and arterial thromboembolic (VAT) conditions than any other novel oral anticoagulant:

• The prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) with one or more risk factors


• The treatment of deep vein thrombosis (DVT) in adults


• The treatment of pulmonary embolism (PE) in adults


• The prevention of recurrent DVT and PE in adults


• The prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip replacement surgery


• The prevention of VTE in adult patients undergoing elective knee replacement surgery


• The prevention of atherothrombotic events (cardiovascular death, myocardial infarction or stroke) after an Acute Coronary Syndrome in adult patients with elevated cardiac biomarkers when co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine

It has now been cleared by the US Food and Drug Administration (FDA) for combating the ongoing risk of recurrent venous thromboembolism (VTE). The prescribing information of rivaroxaban advises beginning the drug at 15 mg dosed twice daily for the first 21 days after VTE and decreasing the dose to 20 mg once daily on day 22 through at least day 180. After at least 180 days, physicians may now prescribe rivaroxaban 10 mg once daily in patients at continued risk for VTE, the company said.

The FDA considered a review of rivaroxaban 10 mg once daily on priority basis after evaluating 6 months of initial treatment based on data from the EINSTEIN CHOICE trial presented at the American College of Cardiology (ACC) 2017 Scientific Sessions and published in the New England Journal of Medicine.