Pradaxa antidote goes to FDA

Boehringer Ingelheim submitted its Pradaxa antidote (idarucizumab) to the FDA, asking that it be routed through an accelerated approval pathway.

The treatment snagged a Breakthrough Therapy designation in June.

The new wave of blood thinners, which includes Pradaxa, Bristol-Myers Squibb/Pfizer's Eliquis and Johnson & Johnson's Xarelto, has been subject to ping-ponging reports about their effectiveness and safety compared with cheaper standby warfarin.

Correction: An earlier version of this brief misstated information related to idarucizumab's drug class.