The Food and Drug Administration has approved the anti-clotting drug Eliquis (apixaban).
Eliquis is used to lower the risk of stroke and blood clots in patients with atrial fibrillation, the most common form of irregular heartbeat.
The drug has been rejected twice before, with the most recent rejection being handed down in June.
The FDA cleared the drug based on a clinical trial of over 18,000 patients that compared Eliquis with warfarin, another anti-clotting drug. Patients who took Eliquis had fewer strokes than those who took warfarin.
Dr. Norman Stockbridge, director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research, said, “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.”
Eliquis will be made by Bristol-Myers Squibb and marketed by Pfizer. It is the third anti-clotting drug to approved in recent years as a replacement to warfarin, which goes by the brand name Coumadin. It will have to compete with Pradaxa, but the manufacturer, Boehringer Ingelheim, has recently been slammed with lawsuits stemming from a number of deaths and side effects linked to the drug.
Unlike warfarin, Pradaxa (dabigatran) does not have an antidote for uncontrolled bleeding caused by the drug.
Eliquis was approved in Europe in November, and Bristol-Myers said it was the only ant-clotting drug that showed an advantage over warfarin in terms of reducing the risk of stroke and blood clots. Experts have largely agreed with the claim that it offers the best balance of benefits and risks.