Interim results of Phase III RE-VERSE AD trial for BI 655075 (idarucizumab) as antidote- Boehringer Ingelheim

Results from an interim analysis of the Phase III RE-VERSE AD study demonstrated that 5g of BI 655075 (idarucizumab), from Boehringer Ingelheim, enabled emergency surgery to be initiated rapidly in urgent situations involving patients treated with dabigatran (Pradaxa). The specific and immediate reversal of the anticoagulant effect of dabigatran enabled patients to be urgently brought to necessary procedures, with a median time of 1.7 hours between administration of idarucizumab and start of procedure. The interim analysis from RE-VERSE AD included data from patients requiring emergency surgery or an invasive procedure (e.g., surgery for an aortic aneurysm or an open fracture after a fall), which could not be delayed for more than 8 hours. There were no post-surgical bleeding complications reported in the 24 hours following surgery. The results were presented at the ESC Congress 2015.

Comment: RE-VERSE AD, a phase III 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. Boehringer Ingelheim has had to settle 4,000 lawsuits in the USA 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.