“Blockbuster” drug approved by FDA
NEW YORK, NY: The Food and Drug Administration on Friday approved Eliquis, an anticlotting 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 anticlotting drug Eliquis is expected to be a blockbuster for Bristol-Myers Squibb and Pfizer.
Dr. Garret FitzGerald, a cardiologist, said the trial results for the drug were impressive.
The agency approved Eliquis for reducing the risk of stroke and dangerous blood clots in people withatrial fibrillation, a common heart arrhythmia that afflicts millions of people in the United States.
The drug, also known as apixaban, is the third anticlotting 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 now 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, Dr. Kaul said since there have been no clinical trials comparing the three new 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 newsrelease 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 e-mail on Friday: “What matters to a patient is the individual effect in them.”
He noted that patients taking Eliquis also suffered major bleeding episodes and said all drugs that prevent clotting carried a risk of bleeding. “Thus the F.D.A.’s warning to be on the lookout for bleeding seems just as appropriate as approval of Eliquis,” he said.
Dr. Kaul says he tends to wait to prescribe new drugs until he learns more from the experience of colleagues, and Eliquis will be no exception. “I’m going to sit back by the sidelines and see how it pans out,” he said, adding that he had begun to prescribe Pradaxa and Xarelto to patients.
Eliquis’s entry into the United States market has been eagerly anticipated by Bristol-Myers and Pfizer after a succession of delays this year. Bristol-Myers, in particular, has been struggling since its best-selling blood-thinner drug, Plavix, lost its patent protection in May. Sales of Plavix, which Bristol-Myers sells in partnership with Sanofi, fell 96 percent in the third quarter of this year after cheaper generic alternatives flooded the market and the company has struggled to replace the lost sales.
Eliquis is “very important for Bristol because it’s one of the legs of their investment case, that they can leapfrog over the Plavix expiration,” said Les Funtleyder, the fund manager of Poliwogg, a private equity and hedge fund. He said he expected Eliquis to eventually earn more than $1 billion for its sellers.
In such a crowded field of competitors, Mr. Funtleyder said, consumers and doctors should brace themselves for a marketing onslaught. “I wonder if we’ll see our first Eliquis commercial before the new year,” he said.