FDA Approves Rivaroxaban to Prevent Strokes in Afib Patients

The anticoagulant rivaroxaban (brand name, Xarelto) has been approved to reduce the risk for stroke in patients with nonvalvular atrial fibrillation, the FDA announced on Friday. The drug, a factor Xa inhibitor, is the second warfarin alternative to be approved in just over a year.

In September, an FDA advisory panel voted 9 to 2 to recommend the approval after the ROCKET AF trial found that rivaroxaban was as effective as warfarin in preventing stroke. (Some analysts questioned this finding, as warfarin was not always dosed properly in the trial.)

Similar to other anticoagulants, rivaroxaban carries a risk for major bleeding. In ROCKET AF, it caused less intracranial bleeding, but more gastrointestinal bleeding, than warfarin.

Rivaroxaban was previously approved for preventing venous thromboembolism after hip or knee replacement.