US Food and Drug Administration (FDA) has approved Janssen Pharmaceuticals' oral anticoagulant, Xarelto to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Xarelto is the only oral anticoagulant approved in the US that offers once-daily dosing, without the need for routine blood monitoring.

In addition to this new indication, Xarelto is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE) in people undergoing knee or hip replacement surgery. Xarelto has been used by more than a million patients worldwide in the orthopaedic setting. Xarelto belongs to a group of medicines called anticoagulants. It works by blocking the blood clotting Factor Xa and thereby reduces the tendency of the blood to form clots.

Gerald V. Naccarelli, M.D., Professor of Medicine, Chief of Division of Cardiology, Pennsylvania State University College of Medicine and Milton S. Hershey Medical Center said, “Today’s approval of Xarelto offers physicians a new option to reduce stroke risk in patients who are living with atrial fibrillation, and the continuous threat of strokes,” “A majority of my atrial fibrillation patients are on multiple medicines for conditions that further increase the risk of stroke. I welcome a therapy like Xarelto that has demonstrated effectiveness and safety in these patients, with the added convenience of a once-daily dose.”

Xarelto is approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation 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. There are limited data on the relative effectiveness of Xarelto and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well-controlled.

Atrial fibrillation (AFib) is the most common cardiac rhythm disorder and affects more than 2.2 million people in the US. In patients with AFib, the heart’s irregular heartbeat makes them vulnerable to the formation of a blood clot in the atria, which sometimes can break off and travel to the brain, potentially resulting in a stroke. The presence of common conditions such as high blood pressure, heart failure, diabetes, and prior stroke, along with being over the age of 75, are factors that further increase the risk of stroke in people living with AFib. People living with AFib are at a five-fold increased risk for stroke compared with the general population.

“The prevalence of atrial fibrillation is increasing, and many patients who are at risk for stroke are not currently being managed effectively or optimally,” said Robert M. Califf, M.D., ROCKET AF study co-chairman and vice chancellor for clinical research at Duke University. “In clinical studies, Xarelto was shown to be effective in patients who are at increased risk of stroke, and especially in those with co-morbidities such as high blood pressure or diabetes, and other factors that increase the risk of stroke. These patients represent many of those with the most to gain from effective anticoagulation.”

The approval of Xarelto 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 Atrial Fibrillation) global clinical trial, in which once-daily rivaroxaban effectively reduced the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, 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 the categories of bleeding resulting in transfusions and gastrointestinal bleed, more events were observed with rivaroxaban. To see the details of the ROCKET AF trial published in the New England Journal of Medicine, please click here.

“Today’s FDA approval of Xarelto gives patients with nonvalvular atrial fibrillation a new anticoagulation option – one that helps reduce the risk of stroke and has proven tolerability and convenient once-daily dosing and administration,” said Peter M. DiBattiste, M.D., Global Therapeutic Area Head, Cardiovascular and Metabolism, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD). “We are pleased to bring to market a medicine that will potentially help millions of patients.”
Janssen Pharmaceuticals, Inc. holds US marketing rights for Xarelto, and will be supported by the Bayer HealthCare U.S. sales force in designated hospital accounts.

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