Praxbind Gains Full FDA Approval as Pradaxa Reversal Agent
Boehringer Ingelheim announced that the Food and Drug Administration (FDA) has granted full approval for Praxbind (idarucizumab) for use in patients treated with Pradaxa (dabigatran etexilate mesylate) when reversal of anticoagulant effects is needed for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding.
Praxbind was initially granted accelerated approval by the FDA in October 2015; continued approval was pending results from the Phase 3 RE-VERSE AD trial (N=503). The latest analysis included findings from patients requiring urgent procedures/emergency surgery (eg, surgery for an open fracture after a fall) or patients with either uncontrolled or life-threatening bleeding complications (eg, intracranial hemorrhage, severe trauma after car accident). The primary endpoint was the degree of reversal of the anticoagulant effect of Pradaxa achieved by Praxbind within 4 hours.
The final study data, published in July 2017, demonstrated that Praxbind immediately reversed the anticoagulant effect of Pradaxa. Complete reversal was seen within 4 hours in the majority of patients, as measured by ecarin clotting time (ECT 82%) or diluted thrombin time (dTT 99%). In addition, there was a low rate of thrombotic events and no new safety events were reported.
Praxbind, a humanized monoclonal antibody fragment, is available as 2.5g/50mL strength solution for intravenous (IV) infusion in single-use vials.
For more information call (800) 542-6257 or visit Praxbind.com.