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Rivaroxaban approved to reduce risk for stroke, systemic embolism in AF
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The FDA today announced approval of rivaroxaban to reduce risks for stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
Rivaroxaban (Xarelto, Johnson & Johnson) was approved as a once-daily 20-mg dose for patients with nonvalvular AF or a 15-mg dose for patients with moderate to several renal impairment. Patients should take rivaroxaban with an evening meal.
According to the company, rivaroxaban is the only oral anticoagulant approved in the US that offers once-daily dosing, without the need for routine blood monitoring.
"Today's FDA approval of [rivaroxaban] gives patients with nonvalvular AF a new anticoagulation option - one that helps reduce the risk of stroke and has proven tolerability and convenient once-daily dosing and administration," Peter M. DiBattiste, MD, head of cardiovascular research at Johnson & Johnson, stated in a company press release. "We are pleased to bring to market a medicine that will potentially help millions of patients."
Approval was supported by data from the pivotal, double blind, phase 3 ROCKET AF trial. Results showed that once-daily rivaroxaban effectively reduced the risk for stroke and systemic embolism in patients with nonvalvular AF, with major bleeding rates comparable to warfarin. In bleeding categories of great concern, such as bleeding into a critical organ and fatal bleeding, fewer events were observed with rivaroxaban. In categories of bleeding resulting in transfusions and gastrointestinal bleed, more events were observed with rivaroxaban.
The FDA is requiring a Risk Evaluation and Mitigation Strategy (REMS), consisting of a medication guide and communication plan, to communicate potential risks associated with rivaroxaban.
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