The FDA has approved rivaroxaban (Xarelto, Bayer HealthCare/Janssen Pharmaceuticals) to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF).

Rivaroxaban now will be the only oral anticoagulant approved in the U.S. that offers once-daily dosing, without the need for routine blood monitoring.

Rivaroxaban is approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular AF at a dose of 20 mg once daily, or 15 mg once daily for patients with moderate to severe renal impairment, taken with the evening meal, according to Janssen, which is a Johnson & Johnson company. There are limited data on the relative effectiveness of rivaroxaban and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well-controlled, the firm added.

The approval of rivaroxaban in this indication was based on the pivotal, double-blind Phase 3 ROCKET AF (Rivaroxaban Once-daily oral direct Factor Xa inhibition Compared with vitamin K antagonism for the prevention of stroke and Embolism Trial in AF) trial, in which once-daily rivaroxaban effectively reduced the risk of 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. However, in the categories of bleeding resulting in transfusions and gastrointestinal bleed, more events were observed with rivaroxaban.

In September, the FDA’s Cardiovascular and Renal Drug committee recommend that the FDA approve the oral Xa Inhibitor for the prevention of stroke and systemic embolism in nonvalvular AF patients. The vote was nine to two with one abstention. The majority, however, said that it merits a claim for patients failing other anticoagulant therapy, rather than a superiority claim or alternative to warfarin.

Since that time, the drug has garnered some criticism, from New England Journal of Medicine editorials to nonprofit advocacy groups, like Public Citizen, which questioned whether the FDA should approve the drug.

The FDA has required a Risk Evaluation and Mitigation Strategy (REMS) for rivaroxaban to communicate the risks of increased risk of thrombotic events, including stroke, if rivaroxaban is discontinued without introducing an adequate alternative anticoagulant in patients with nonvalvular AF, and the potential decreased efficacy of rivaroxaban (15 mg and 20 mg) if not taken with the evening meal. The rivaroxaban REMS consists of a Medication Guide and a communication plan.