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.
On Friday, the FDA approved the company's Praxbind, a reversal agent for patients taking the German drugmaker's clot-fighter Pradaxa. As Dr. Richard Pazdur, hematology director at the FDA's Center for Drug Evaluation and Research, explained in a statement, the new product is "an important tool for managing patients taking Pradaxa in emergency or life-threatening situations when bleeding can't be controlled."
The way Charles Pollack, the leader of BI's Phase III study for Praxbind, sees it, having a reversal agent in such situations will help "get the concern off the physician's plate so that he or she can focus" on whatever else needs to happen in the emergency room," he told FiercePharma in an August interview.
All next-gen blood thinners--Pradaxa, market-leader Xarelto from Johnson & Johnson ($JNJ) and Bayer, Eliquis from Pfizer ($PFE) and Bristol-Myers Squibb ($BMY), and newcomer Savaysa from Daiichi Sankyo--come with bleeding risks. The absence of an antidote has kept some doctors loyal to old-guard therapy warfarin, despite its more difficult dosing and requirement for ongoing monitoring.
Now, Praxbind "may very well take some of that insecurity away," Pollack predicted.
And it may also help Boehringer pick up ground against Xarelto. The J&J and Bayer med, which won FDA approval after Pradaxa, has since eclipsed the market's No. 1 spot, in part thanks to a large clinical trial program that's helped it earn a broader label than those of its competitors.
That's a spot BI would like to have back. It'll have to work quickly, though, as its rivals have their own reversal agent in the works. Portola Pharma is currently testing its antidote in Phase III, and it's entered collaboration agreements with Daiichi and both the J&J/Bayer and Pfizer/BMS teams.
- read the FDA's release
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