Aims: Because practice-based data on the usage of idarucizumab for urgent dabigatran reversal is unavailable, we evaluated the appropriateness of idarucizumab usage, its haemostatic effectiveness and clinical outcomes.
Boehringer has submitted BI 655075 (idarucizumab) for approval of marketing authorisation to the European Medicines Agency (EMA) and Health Canada,...
Although dabigatran has a favorable risk-benefit profile compared with vitamin K antagonist therapy for venous thromboembolism and nonvalvular atrial fibrillation, major bleeding events, including gastrointestinal (GI) bleeding...
Evaluate the reversal of the anticoagulant effects of dabigatran by IV administration of 5.0g idarucizumab in patients treated with dabigatran...
Intravenous thrombolysis with recombinant tissue plasminogen activator (rt-PA) for acute ischemic stroke (AIS) is contraindicated in patient taking either Factor Xa inhibitors or direct thrombin inhibitors.
Use of non-vitamin K antagonist oral anticoagulants is spreading in the real world. Despite that, a strong need for antidotes/reversal agents is still reported by several physicians.
The FDA has granted approval of Praxbind (idarucizumab), from Boehringer Ingelheim, indicated for patients treated with Pradaxa (dabigatran etexilate mesylate),...
The European Commission has licensed Praxbind (idarucizumab), from Boehringer Ingelheim, a treatment to rapidly and specifically reverse the anticoagulant effects...
Boehringer has submitted a biologics license application (BLA) to the FDA requesting an Accelerated Approval pathway, for the use of...