FDA approves Pfizer, BMS warfarin alternative

Bristol-Myers Squibb ($BMY) and Pfizer ($PFE) have finally gotten the coveted FDA approval of their blood thinner Eliquis. The question now is, with two warfarin alternatives having beat it to the market, can it still reach its potential, an estimated $5 billion in peak annual sales?

The FDA approved Eliquis for reducing risk of stroke and blood clots in patients with non-valvular atrial fibrillation. The agency said it shouldn't be used in patients with artificial heart valves or defective heart valves.

The FDA twice delayed ruling on the drug, first saying it needed more time and then more information on which to base a decision, even as Europe and Canada and gave it their blessing. Japan approved it this week. But with the U.S. being the largest market, the two companies were anxious to get it approved here as soon as possible. The agency was not slated to rule until March 17. Pfizer and Bristol-Myers will split sales. Bloomberg, citing Centers for Disease Control and Prevention statistics, reported that an estimated 2.66 million people in the U.S. suffer from atrial fibrillation.

There is data that suggests that Eliquis could be the best of the alternatives to side-effect-heavy warfarin, but two other drugs have beat it to the U.S., giving them a leg up. Those are Johnson & Johnson's ($JNJ) Xarelto and Boehringer Ingelheim's Pradaxa. Pradaxa has already surpassed the billion-dollar sales mark, but last week the FDA warned doctors that it, too, should not be used in patients with mechanical heart valves, pointing out that a study was stopped because they "were more likely to experience strokes, heart attacks and blood clots forming on the mechanical heart valves than were users of the anticoagulant warfarin."

- here's the release
- see The Wall Street Journal's article (sub. req.)
- check out Bloomberg's report
- and the item from Reuters

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