Janssen receives FDA approval for Xarelto to prevent stroke in people with AF

U.S. Food and Drug AdministrationNov 5 2011

The U.S. Food and Drug Administration today approved the anti-clotting drug Xarelto (rivaroxaban) to reduce the risk of stroke in people who have abnormal heart rhythm (non-valvular atrial fibrillation).

Atrial fibrillation occurs in more than 2 million Americans and is one of the most common types of abnormal heart rhythm. In atrial fibrillation, the beating of the heart's two upper heart chambers (atria) is irregular and poorly coordinated. This leads to blood pooling in these chambers, resulting in blood clots. Non-valvular atrial fibrillation refers to atrial fibrillation in patients who do not have significant problems in their heart valves.

"Atrial fibrillation can lead to the formation of blood clots, which can travel to the brain, blocking blood flow and causing a disabling stroke," said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Products in the FDA's Center for Drug Evaluation and Research. "This approval gives doctors and patients another treatment option for a condition that must be managed carefully."

A stroke occurs if the flow of blood to a portion of the brain is blocked. If brain cells die or are damaged because of a stroke, symptoms occur in the parts of the body that these brain cells control. Stroke symptoms include sudden weakness; paralysis or numbness of the face, arms, or legs; trouble speaking or understanding speech; and trouble seeing.

The safety and efficacy of Xarelto were evaluated in a clinical trial with more than 14,000 patients comparing Xarelto with the anti-clotting drug warfarin. In the trial, Xarelto was similar to warfarin in its ability to prevent stroke.

For people taking the drug for atrial fibrillation, Xarelto should be taken one time a day with the evening meal so that it will be completely absorbed.  

As with other anti-clotting drugs, Xarelto can cause bleeding that, rarely, can lead to death. Bleeding was the most common adverse event reported by patients treated with Xarelto in the major clinical trial for the prevention of stroke in non-valvular atrial fibrillation. In that trial, Xarelto's risk of major bleeding was similar to that of warfarin; however, it caused less bleeding into the brain and more bleeding into the stomach and intestines.

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.

An FDA-required Medication Guide, which will be given to patients and caregivers when Xarelto is dispensed, describes the risks and adverse reactions people should be mindful of when using the drug.

Xarelto is marketed in the United States by Titusville, N.J.- based Janssen Pharmaceuticals Inc.