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American College of Cardiology 2013

Similar Bleeding and Thrombotic Complication Rates Between Dabigatran and Rivaroxaban

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.
Drugs in the Pipeline

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 to reverse the anticoagulant effect of Pradaxa (dabigatran etexilate mesylate).
Drugs in the Pipeline

Pradaxa Reversal Agent Works Within Minutes in Phase 3 Study

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).
Drugs in the Pipeline

Priority Review Granted for Pradaxa Reversal Agent

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.
Drugs in the Pipeline

FDA Accepts sNDA for New Pradaxa Indication

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.