FDA approves Bristol-Myers Squibb's Eliquis to reduce risk of stroke, blood clots

PRINCETON, N.J. — The Food and Drug Administration last week approved the anti-clotting drug Eliquis (apixaban), an oral tablet used to reduce the risk of stroke and dangerous blood clots in patients with atrial fibrillation that is not caused by a heart valve problem. Eliquis is manufactured by Bristol-Myers Squibb, and marketed by BMS and Pfizer.

Atrial fibrillation — one of the most common types of abnormal heart rhythm — is an abnormal, irregular and rapid beating of the heart in which the heart’s two upper chambers (i.e., atria) do not contract properly, allowing blood clots to form in them. These clots can break off and travel to the brain or other parts of the body.

“Blood clots in the heart can cause a disabling stroke if the clots travel to the brain,” said Norman Stockbridge, director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research. “Anti-clotting drugs lower the risk of having a stroke by helping to prevent blood clots from forming.”

The safety and efficacy of Eliquis in treating patients with atrial fibrillation not caused by cardiac valve disease were studied in a clinical trial of more than 18,000 patients that compared Eliquis with the anti-clotting drug warfarin. In the trial, patients taking Eliquis had fewer strokes than those who took warfarin.