Portola Pharmaceuticals has laid out the last batch of Phase III data on its "breakthrough" anti-anticoagulant andexanet alfa, filling in the numbers that will be reviewed by regulators considering the biotech's upcoming pitch for marketing approval. And right alongside that announcement comes the latest numbers from Boehringer Ingelheim's breakthrough program for idarucizumab, which is already under review as an antidote to its blockbuster Pradaxa.
On Wednesday, Pfizer and Bristol-Myers Squibb got some positive data on an undo med for their market trailer, Eliquis. And that antidote could be on the way in the not-too-distant future.
Catheter-directed thrombolysis (CDT) has been used in an effort to reduce the incidence of post-thrombotic syndrome in deep vein thrombosis. But a newly published observational study suggests that not only is catheter use ineffective at preventing post-thrombotic syndrome, but it is actually associated with higher rates of adverse events.
While their makers fight lawsuits and regulators keep watch on safety questions, the U.K.'s cost-effectiveness gatekeepers figure the new generation of anticoagulants should be used more to fight stroke, not less.
Boehringer Ingelheim has agreed to pay $650 million to wrap up thousands of lawsuits claiming Pradaxa, an anticoagulant, caused serious--even fatal--bleeding in some patients. The deal comes just weeks after the FDA completed a safety review of the drug, concluding that it was as safe as the older drug it seeks to replace, warfarin.
It turns out that Boehringer Ingelheim's popular anticoagulant Pradaxa is safer than many people think. That is the finding of the FDA after taking another look at the side effects of the drug compared to the old standard warfarin and this time looking at a much larger and older patient base.
What's the safest anticoagulant? According to AdverseEvents, which analyzes and distills data filed with the FDA, that would be Eliquis, the latest entrant into the warfarin alternative market.
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.
German regulators have responded to Der Spiegel 's questions about Xarelto side effects. Answer? The Federal Institute for Drugs and Medical Devices sees no new red flags for patients using the clot-fighting drug developed by Bayer and Johnson & Johnson.