Bristol-Myers Squibb ($BMY) and Pfizer ($PFE), which have yet to get their blood thinner Eliquis approved in the U.S., have gotten a third regulatory nod elsewhere.
Japan approved the warfarin alternative today for the prevention of ischemic stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Eliquis is already approved in the European Union and Canada, but the FDA has twice turned it away, saying it needed more time and more information. It is now set to rule by March 17, an approval that would clear the path for it to reach its blockbuster potential.
There is data that suggests Eliquis could be the best of the alternatives to side-effect-heavy warfarin, but two others 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, which has already surpassed the billion-dollar sales mark, has run into some issues of late over concerns about its bleeding risks. An Australian government agency last week said that given new data, it had decided to reconsider whether to recommend that the government cover its cost. That came despite a recent announcement by the FDA that a further review of data found the bleeding risk for Pradaxa to be no greater than for warfarin.
- here's the press release
- get more from the Associated Press