BI Requesting Accelerated Approval for Pradaxa Reversal Agent
Boehringer Ingelheim announced that it has submitted a Biologics License Application (BLA) to the FDA, requesting accelerated approval for the use of idarucizumab, a humanized antibody fragment to reverse the anticoagulant effect of Pradaxa (dabigatran etexilate mesylate). Pre-clinical studies indicate idarucizumab binds specifically to and inhibits dabigatran.
The BLA submission includes data from Phase 1 volunteers demonstrating that idarucizumab provided immediate, complete and sustained reversal of the anticoagulant effect of dabigatran. Boehringer Ingelheim is continuing to evaluate idarucizumab in RE-VERSE AD, a Phase 3 global study investigating idarucizumab in actual clinical settings. This is the only trial to examine patients being treated with Pradaxa who are in need of emergency intervention or who experience an uncontrolled or life-threatening bleeding event.
Pradaxa is approved to reduce the risk of stroke and systemic embolism in non-valvular atrial fibrillation (AF); treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with parenteral anticoagulant for 5–10 days; and to reduce risk of recurrent DVT/PE in patients who have been previously treated.
For more information call (800) 542-6257 or visit Boehringer-Ingelheim.com.