German family-owned pharma major Boehringer Ingelheim yesterday presented results from two new analyses evaluating idarucizumab, recently approved under the Accelerated Approval pathway and marketed in the USA as Praxbind, a specific reversal agent for its blockbuster anticoagulant Pradaxa (dabigatran etexilate mesylate) at the American Heart Association (AHA) Scientific Sessions 2015 in Orlando.
The analysis examined re-initiation of antithrombotic therapy after administration of idarucizumab. The re-initiation of antithrombotic therapy in patients with non-valvular 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 re-initiation of alternative antithrombotic therapy was possible any time after idarucizumab use. Re-initiation of alternative antithrombotic therapy (eg, 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. Re-initiation of Pradaxa 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.
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