The FDA has accepted for review the sNDA for Pradaxa (dabigatran etexilate mesylate; Boehringer Ingelheim) in patients with deep vein thrombosis (DVT) and pulmonary embolism (PE).
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 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).
For patients initiating oral anticoagulant therapy, the incidence of hospitalization for upper gastrointestinal bleeding is highest and lowest with rivaroxaban and apixaban, respectively.
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).
