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Pharmaceuticals / Submissions and Approvals

FDA Approves New Lower-dose Xarelto

Nov. 3, 2017

The FDA approved a new 10 mg once-daily dose of Xarelto (rivaroxaban) for reducing the risk for recurrent venous thromboembolism, including deep vein thrombosis and pulmonary embolism, after completing six months of anticoagulation therapy. The agency had granted the Janssen’s blood thinner a priority review.

The approval was based on a Phase III trial that found Xarelto, a factor Xa inhibitor, demonstrated superior efficacy in reducing risk with major bleeding rates similar to aspirin. The European Commission granted approval to the same dose earlier in October.

The updated FDA prescribing information provides for treatment to start with Xarelto 15 mg twice daily for the first 21 days after a VTE occurrence. On day 22 through at least six months, the daily dose decreases to 20 mg once daily. After that, physicians can prescribe 10 mg once daily in patients at continued risk.

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