The FDA has granted Breakthrough Therapy designation to idarucizumab (Boehringer Ingelheim), an investigational fully humanized antibody fragment (Fab), being evaluated as a specific antidote for Pradaxa (dabigatran etexilate mesylate).
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Boehringer Ingelheim announced results from an interim analysis of the Phase 3 RE-VERSE AS patient study with idarucizumab for urgent reversal of the anticoagulant effect of Pradaxa (dabigatran etexilate mesylate).
The greatest risk reduction of stroke or systemic embolism was seen with dabigatran 150mg twice daily (odds ratio [OR] 0.65, 95% CI: 0.52-0.81), followed by apixaban 5mg twice daily (OR 0.79, 95% CI: 0.66-0.94).
Study patients were randomized to Pradaxa 150mg twice daily or warfarin (target INR 2-3) and remained on this treatment for the trial duration.
Interim results of a retrospective analysis comparing major bleeding events in patients treated with Pradaxa (dabigatran etexilate mesylate; Boehringer Ingelheim) and warfarin were announced at the American Heart Association’s Scientific Session 2014.
The Food and Drug Administration (FDA) has granted Priority Review to the Biologics License Application (BLA) for idarucizumab (Boehringer Ingelheim) to reverse the anticoagulant effect of Pradaxa (dabigatran etexilate mesylate) in patients needing emergency intervention or experiencing an uncontrolled or life-threatening bleeding event.
The American College of Chest Physicians has released the latest evidence-based guideline with updated recommendations for appropriate treatment of patients with venous thromboembolism (VTE).
To compare the incidence of hospitalization for upper GI tract bleeding, researchers used US Medicare beneficiary files to identify a cohort of patients that were ≥30 years old who initiated oral anticoagulation therapy with apixaban, dabigatran, rivaroxaban, or warfarin, with or without PPI cotherapy.
Idarucizumab (Praxbind) was recently granted accelerated approval as a reversal agent for patients on Pradaxa during emergency situations.
Boehringer Ingelheim announced that the Pradaxa (dabigatran etexilate mesylate capsules) prescribing information has been updated to affirm that Pradaxa 150mg twice daily was superior in reducing ischemic and hemorrhagic strokes relative to warfarin