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Your search for dabigatran returned 9 results

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Dabigatran Comparable to Warfarin in DVT/PE Trial

Boehringer Ingelheim announced results from the RE-COVER II study evaluating dabigatran compared to warfarin in patients diagnosed with acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
Drugs in the Pipeline

Antidote for Pradaxa Demonstrates Efficacy in Study

Boehringer Ingelheim announced results demonstrating that its investigational fully humanized antibody fragment (Fab) rapidly reversed the anticoagulation effect of dabigatran in healthy male volunteers.
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

Rapid Reversal Seen With Idarucizumab in Pradaxa-Treated Patients

Boehringer Ingelheim presented positive results of its Phase 3 RE-VERSE AD study for idarucizumab as a reversal agent for the anticoagulant effect of Pradaxa (dabigatran) in patients needing emergency surgery or for life-threatening or uncontrolled bleeding events.
Drugs in the Pipeline

Pradaxa Under Review for DVT and PE

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).
Drugs in the Pipeline

Pradaxa Antidote, Idarucizumab Designated Breakthrough Therapy

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).
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.