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The Food and Drug Administration on Friday approved Eliquis, an anti-clotting drug that has been highly anticipated by cardiologists and is expected to be a blockbuster for Bristol-Myers Squibb, which will make the drug, and Pfizer, which will help market it.
The agency approved Eliquis for reducing the risk of stroke and dangerous blood clots in people with atrial fibrillation, a common heart arrhythmia that afflicts millions of people in the United States.
The drug, also known as apixaban, is the third anti-clotting medicine to be approved in recent years, and the companies are expected to aggressively compete to pitch their products as a replacement for warfarin, an older treatment that requires more careful monitoring. Warfarin is also known by the brand name Coumadin.
"The marketing games will now begin," said Dr. Sanjay Kaul, a cardiologist at the Cedars-Sinai Medical Center in Los Angeles, who was not involved in the development of any of the drugs.
He said that cardiologists would have to sort out the differences among Eliquis and its competitors already on the market: Pradaxa, sold by Boehringer Ingelheim, and Xarelto, sold by Johnson & Johnson and Bayer.
While some experts have argued that Eliquis offers the best balance between the drug's benefits and risks, Kaul said that since there have been no clinical trials comparing the three drugs, "it is impossible to adjudicate which of these new agents is the preferred one."
Bristol-Myers and Pfizer issued a brief statement Friday saying they were pleased with the approval. In a news release in November announcing the drug's approval in Europe, Bristol-Myers noted that Eliquis was the only drug in the group that has shown an advantage over warfarin in reducing the risk of stroke and dangerous blood clots, major bleeding and death.
The agency also warned that patients with prosthetic heart valves should not take Eliquis, nor should patients with atrial fibrillation that is caused by a heart valve problem.
Despite the promise of Eliquis and the other new drugs, some cautioned against prescribing them too enthusiastically.
Dr. Garret FitzGerald, a cardiologist and chairman of pharmacology at the University of Pennsylvania, said the trial results for Eliquis were impressive.
But he added in an email Friday: "What matters to a patient is the individual effect in them."