The lack of an antidote to reverse the effects of new-age anticoagulants has kept some doctors from prescribing them. But now, Boehringer Ingelheim is hoping that'll change.
Boehringer Ingelheim picked up an FDA nod for an injection designed to reverse the effects of its blockbuster anticoagulant Pradaxa, marking the first approval for an antidote to a next-generation blood thinner.
Boehringer Ingelheim's next-gen anticoagulant, Pradaxa, has been plagued by safety worries that have cropped up since its 2010 FDA approval. And according to one watchdog group, that's because the agency was "lax" and "permissive" in reviewing the drug in the first place.
LONDON-- Boehringer Ingelheim's Pradaxa currently trails Johnson & Johnson and Bayer med Xarelto in the market for new-age anticoagulants, but the German drugmaker is hoping a nod for its antidote candidate will help turn the tide in its favor.
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.
Boehringer Ingelheim submitted U.S., European and Canadian applications for an antidote to its own Pradaxa, leading the way among companies developing treatments that reverse the effects of blockbuster next-generation anticoagulants.
What's long been a three-horse race just gained a fourth horse with the FDA's green light for Daiichi Sankyo's clot-fighter Savaysa. With the FDA's Thursday blessing, the drug will now face down a new-age anticoagulant trifecta that's been duking it out in the marketplace for a while now.
This week, the U.K. National Institute for Health and Care Excellence blessed Pfizer's kidney cancer treatment Inlyta, changed its mind in support of Bayer's prostate cancer therapy Xofigo, and backed Boehringer Ingelheim's anticoagulant Pradaxa for blood clots in the legs and lungs.
The safety message on Boehringer Ingelheim's key product, Pradaxa, has been mixed. But the German drugmaker has rolled out some new studies that show its effectiveness, as well as some promising data about the antidote being developed to treat serious bleeding in Pradaxa patients.
One drug. Two new safety studies promoted on the same day. Two different conclusions. That's the situation with Pradaxa, the Boehringer Ingelheim anticoagulant that's drawn scrutiny for reports of serious bleeding--and prompted safety reviews in the U.S. and EU