FDA approves BMS and Pfizer’s anticlotting drug, Eliquis

Hannah Blake

pharmaphorum

The anticlotting drug, Eliquis, has been approved for use in the United States by the country’s regulatory body, the Food and Drug Administration (FDA). Eliquis is manufactured by Bristol-Myers Squibb (BMS) and will be marketed by BMS and Pfizer.

Eliquis (apixaban) is an oral tablet used to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem. Atrial fibrillation is one of the most common types of abnormal heart rhythm, and is when the heart beats irregularly, causing the heart’s two upper chambers to not contract properly, which allows blood clots to form in them.

“Blood clots in the heart can cause a disabling stroke if the clots travel to the brain. Anti-clotting drugs lower the risk of having a stroke by helping to prevent blood clots from forming.”

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.

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.

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