FDA Approves New Dose for VTE Drug
The US Food and Drug Administration has approved the 10 mg once-daily dose of Xarelto (rivaroxaban) for reducing the risk of recurrent venous thromboembolism (VTE) in patients who have completed at least 6 months of initial anticoagulation therapy.
Approval was based on data from the EINSTEIN CHOICE randomized control trial, which demonstrated Xarelto superiority to aspirin for reducing the risk of recurrent VTE with similar major bleeding rates.
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The most common adverse event associated with Xarelto was bleeding. The drug is not indicated for patients with artificial heart valves.
FDA approves new 10 mg dosing for Xarelto ® (rivaroxaban) to reduce the continued risk of venous thromboembolism [press release]. Titusville, NJ: Janssen Inc., October 31, 2017. http://www.janssen.com/fda-approves-new-10-mg-dosing-xareltor-rivaroxaban-reduce-continued-risk-venous-thromboembolism-vte. Accessed November 1, 2017.