FDA Accepts sNDA for New Pradaxa Indication

Boehringer Ingelheim announced that the Food and Drug Administration (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.

The submission is based on the results of two randomized, double-blind, phase III trials, RE-NOVATE and RE-NOVATE II. The studies compared the efficacy and safety of Pradaxa to enoxaparin in preventing venous thromboembolism (VTE) and death in patients undergoing total hip replacement surgery. The results showed patients taking Pradaxa 220mg had a lower composite total of VTE (VTE comprises DVT and PE) and all-cause death (6.0%) than those on Pradaxa 150mg (8.6%) and on enoxaparin 40mg (6.7%).

RELATED: BI Requesting Accelerated Approval for Pradaxa Reversal Agent

Pradaxa is approved to reduce the risk of stroke and systemic embolism in non-valvular atrial fibrillation (AF), for treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with parenteral anticoagulant for 5–10 day, 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.

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