US FDA finally approves Bristol-Myers/Pfizer's Eliquis for stroke prevention in AF patients

The US Food and Drug Administration on December 28 finally approved the anti-clotting drug Eliquis (apixaban), 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 which is co-marketing by Bristol-Myers Squibb (NYSE: BMY) and Pfizer (NYSE: PFE), leading the shares of the companies to rise 1.9% to $31.90 and just under 1% to $24.99, respectively.

The drug was recently approved for these indications in Europe (The Pharma Letter November 22) and Japan (TPL December 27), but has previously been rejected by the FDA, most recently this summer (TPL June 26). Eliquis will come to the US market somewhat later than other new anti-clotting agents for patients with atrial fibrillation, namely Pradaxa (dabigatran etexilate) and Xarelto (rivaroxaban) from German drug majors Boehringer Ingelheim and Bayer (BAYN: DE; partnered with Johnson & Johnson [NYSE: JNJ]), respectively
“The marketing games will now begin,” said Sanjay Kaul, a cardiologist at the Cedars-Sinai Medical Center in Los Angeles quoted by the New York Times, 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 and Xarelto). 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.”

Sales could reach $5.2 billion a year by 2020