FDA approves rivaroxaban to prevent stroke in non-valvular atrial fibrillation patients

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The US Food and Drug Administration (FDA) announced on 4 November 2011 approval of the anticoagulant drug rivaroxaban (Xarelto, Bayer Healthcare) to reduce the risk of stroke in non-valvular atrial fibrillation patients. In September 2011, FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 9−2 (with one abstention) to approve rivaroxaban in this indication.

Norman Stockbridge, director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research, commented, “This approval gives doctors and patients another treatment option for a condition that must be managed carefully.”


The FDA’s approval is largely based on the results from the ROCKET-AF trial, a double-blind global phase III study that compared once-daily rivaroxaban with warfarin in more than 14,000 patients. This study demonstrated the safety and efficacy of rivaroxaban. On the principal safety measure of major and non-major clinically relevant bleeding events, rivaroxaban was similar compared with warfarin. Rates of major bleeding were also comparable between rivaroxaban and warfarin. Importantly, patients treated with rivaroxaban had fewer intracranial haemorrhages, fewer critical organ bleeds and lower bleeding-related deaths than those on warfarin.


The results from the ROCKET-AF trial were presented at the American Heart Association (AHA) congress in November 2010 and published in the New England Journal of Medicine in August 2011.


The FDA stated that a Medication Guide describing the risks and adverse reactions of using rivaroxaban will be given to patients and caregivers when the anticoagulant is dispensed. As part of the warnings, the FDA says, “Xarelto has a boxed warning to make clear that people using the drug should not discontinue it before talking with their health care professional. Discontinuing the drug can increase the risk of stroke.”


Rivaroxaban is currently approved in the USA and the European Union for the prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery.


As reported by Cardiac Rhythm News in late September, the European Committee for Medicinal Products for Human Use (CHMP) has recommended rivaroxaban for the treatment of deep vein thrombosis as well as for the prevention of stroke and non-central nervous systemic embolism in adult patients with non-valvular atrial fibrillation. Final approval by the European Committee in these indications is expected by the end of 2011.

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