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New Anti-Clotting Drug Eliquis Approved

Dec 30, 2012 07:08 AM EST

The Food and Drug Administration (FDA) has approved a new drug called Eliquis, developed for treating patients suffering from atrial fibrillation.

The anti-clotting drug Eliquis, manufactured by Bristol-Myers Squibb and co-marketed with Pfizer, was earlier rejected twice by the FDA for want of more information from company trials. This Friday (Dec. 28) the agency cleared the drug to be used for treating atrial fibrillation and lowering the risk of blood clots and stroke, reports The Associated Press.

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

Atrial fibrillation (irregular heartbeat) is a common type of arrhythmia. It is a condition in which fast, disorganized electrical signals cause the heart's two upper chambers (called the atria) to contract rapidly and irregularly (fibrillate).

Although atrial fibrillation might not cause any symptoms, if not noticed, it could increase the risk of stroke. It might appear rarely or might become a long-term heart problem that persists for years.

For many years, a drug called warfarin was prescribed to patients to prevent blood clots and treat irregular heartbeats. The drug was cheap, but required patients to take blood tests in order to make sure that they received right amounts of the drug to prevent strokes and not a high dose that could trigger internal bleeding, the AP report said.

In a clinical trial to test the effectiveness of Eliquis, more than 18,000 patients were treated with the newly-approved drug and compared with those treated with warfarin. The drugmakers found that the patients who took Eliquis had fewer strokes compared to others who took warfarin.

Patients with prosthetic heart valves and those having atrial fibrillation caused by a heart valve problem were not part of the clinical trial. Hence, the FDA has warned these patients to refrain from taking Eliquis.  

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