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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.

Boehringer Ingelheim announced that the FDA has accepted for filing the supplemental New Drug Application (sNDA) for Pradaxa (dabigatran etexilate mesylate) for the prophylaxis of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have had primary elective total hip replacement surgery.

At ACC.13, the American College of Cardiology’s 62nd Annual Scientific Session, Anil Rajendra, MD, from the Medical University of South Carolina, in Charleston, SC, presented data showing similar bleeding and thrombotic complication rates at the time of atrial fibrillation ablation (AFA) in patients anticoagulated with dabigatran and rivaroxaban. Dr. Rajendra and colleagues determined that rivaroxaban has an acceptable safety profile for AFA.