Analysis demonstrates reinitiation of antithrombotic therapy after Praxbind (idarucizumab) therapy in atrial fibrillation patients- Boehringer Ingelheim

Boehringer Ingelheim announced results from a new analysis evaluating Praxbind (idarucizumab) in reinitiation of antithrombotic therapy after administration of idarucizumab. The reinitiation of antithrombotic therapy in patients with nonvalvular atrial fibrillation (NVAF) is important in order to address the underlying risk of stroke. An interim analysis of data from the ongoing phase III RE-VERSE AD trial showed reinitiation of alternative antithrombotic therapy was possible any time after idarucizumab use. Reinitiation of alternative antithrombotic therapy (e.g. heparin) after treatment with idarucizumab ranged from 0.2 days to 77.2 days in patients who presented with uncontrolled or life-threatening bleeding and 0 days to 40.8 days in patients requiring emergency surgery or an urgent procedure. Reinitiation of dabigatran after treatment with idarucizumab ranged from 1.3 days to 90.6 days in patients with uncontrolled or life-threatening bleeding, and 1 day to 63.31 days in patients requiring emergency surgery or an urgent procedure. Data were presented at the American Heart Association (AHA) Scientific Sessions 2015.

Comment: RE-VERSE AD, a global study investigating idarucizumab in actual clinical settings, is the only trial to examine patients being treated with Pradaxa who are in need of emergency intervention or experience an uncontrolled or life-threatening bleeding event. Boehringern Ingelheim has had to settle 4,000 lawsuits in the US filed over claims about the extent of bleeding risks associated with Pradaxa. The company has consistently backed the drug's positive benefit-risk profile, when used as directed, as has the FDA.