Fast-track for Eliquis puts Pradaxa, Xarelto on notice

Pradaxa and Xarelto may get heavyweight competition sooner than expected. The FDA has not only accepted Bristol-Myers Squibb ($BMY) and Pfizer's ($PFE) approval application for Eliquis, their new anti-coagulant designed to rival the old standby warfarin, but also put on the fast track. With priority review, FDA has targeted late March for its decision.

That gives Boehringer Ingelheim, which makes Pradaxa, and the Bayer/Johnson & Johnson duo selling Xarelto, just four months to stake out their claims to the warfarin-alternative market. Pradaxa has something of a head start; it's been approved in the U.S. since October 2010 to prevent stroke in atrial fibrillation patients. Xarelto just won the stroke-prevention nod Nov. 4.

The problem is that Eliquis may well end up with a better label than either of its warfarin-alternative competitors. Pradaxa has strong efficacy data, putting it above warfarin at keeping strokes at bay, but so-so results on the risk of severe bleeding. Xarelto is seen as equally safe, provided patients aren't taken off the drug abruptly, but perhaps not as effective as Pradaxa, if "non-inferior" to warfarin.

Eliquis, on the other hand, boasts some strong clinical data showing it's better at its job than warfarin and safer, too. Analysts are predicting it will climb to the top of the market for alternatives. Deutsche Bank's Barbara Ryan, for one, thinks Eliquis could surpass $2.5 billion in sales, Reuters says, with $250 million right out of the gate in 2012. "Our estimates could prove conservative depending on the degree to which warfarin is displaced and the likelihood that Eliquis will hold the No. 1 (market) share position," Ryan wrote to investors.

- read the release from Pfizer and BMS
- see the Reuters coverage