The good news for Daiichi Sankyo: Its new anticoagulant drug matched the old standard-issue drug warfarin at preventing stroke and blood clots. And as far as safety goes, edoxaban beat warfarin by a significant stretch. That's an entree into the warfarin-alternative market, expected to grow to $10 billion over the next several years.
The Institute for Safe Medication Practices has flagged its latest set of side-effect reports to the FDA--and once again, anticoagulant drugs are at the top. Boehringer Ingelheim's Pradaxa, a new-generation pill, and the old standard therapy warfarin together accounted for more than 1,100 of the adverse events reported direcctly to the FDA.
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Boehringer Ingelheim's drugs Pradaxa and Trajenta are both facing obstacles, but sales of both are still growing--and revenues for the company are growing right along with them.
The U.K.'s cost-effectiveness watchdog gave final clearance to Bayer's anticoagulant drug Xarelto for use in preventing potentially fatal blood clots in the lungs and legs. Meanwhile, Boehringer Ingelheim was filing for European approval for its new-generation anticoagulant, Pradaxa, for similar uses.
Drugmakers, livid with German pricing gatekeepers for turning down so many new drugs, now face a strategy that is sure to ratchet up their anger to the boiling point.
What would top Xarelto for Bayer and Johnson & Johnson? Xarelto with an easy antidote.
The U.K.'s cost-effectiveness watchdogs must really like Eliquis. The new blood thinner from Pfizer ($PFE) and Bristol-Myers Squibb ($BMY) won a thumbs-up for stroke prevention.
Pradaxa, the warfarin alternative from Boehringer Ingelheim, is again under fire only weeks after the FDA released information that the blood thinner was at least as safe as the drug it seeks to supplant.
The approval comes after the drug developers had been stiff-armed twice by the FDA, which has now set a March 17, 2013 PDUFA date on the therapy.