FDA Files Supplemental New Drug Application for Boehringer Ingelheim's Pradaxa® (dabigatran etexilate mesylate) for the Prophylaxis of Deep Venous Thrombosis and Pulmonary Embolism After Hip Replacement Surgery Announced that the U.S. Food and Drug Administration (FDA) filed a 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. If approved, this will become the fourth indication for PRADAXA.
The submission to the FDA is based on the results of two randomized, double-blind, phase III trials, RE-NOVATEand RE-NOVATEII. 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.
In RE-NOVATE, 3,494 patients having primary elective total hip replacement were randomized to three groups receiving prophylactic treatment with one of two doses of PRADAXA (220 mg or 150 mg) once daily or enoxaparin 40 mg once daily for 28 to 35 days. The first PRADAXA group was given a dose of 110 mg on the day of surgery and 220 mg daily thereafter; the second PRADAXA group received a dose of 75 mg on the day of surgery and 150 mg daily thereafter. The enoxaparin group was given a dose of 40 mg the day before surgery and daily thereafter.