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news.Boehringer Ingelheim Pharmaceuticals has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) for Pradaxa for the prophylaxis of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have had primary elective total hip replacement surgery.
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If approved, this will become the fourth indication for Pradaxa (dabigatran etexilate mesylate).
The sNDA is based on the results of two randomized, double-blind Phase III trials, RE-NOVATE and RE-NOVATE II, which compared the efficacy and safety of Pradaxa to enoxaparin in preventing venous thromboembolism (VTE) and death in patients undergoing total hip replacement surgery.
Boehringer Ingelheim Pharmaceuticals Medicine & Regulatory Affairs senior vice-president Sabine Luik said: "Total hip replacement is a common procedure, and preventive anticoagulant treatment is recommended because of the potential for DVT and PE, which can be life-threatening for some patients.
"The acceptance of this sNDA is another step toward expanding the therapeutic uses for Pradaxa to improve patient outcomes in this population."
In RE-NOVATE, a total of 3,494 patients having primary elective total hip replacement were randomized to three groups receiving prophylactic treatment with one of two doses of Pradaxa 220mg or 150mg once daily or enoxaparin 40mg once daily for 28 to 35 days.
Results showed that patients taking Pradaxa 220mg had a lower composite total of VTE and all-cause death (6%) than those on Pradaxa 150mg (8.6%) and on enoxaparin 40mg (6.7%).
In RE-NOVATE II, around 2,055 patients undergoing primary elective total hip replacement were randomly assigned prophylactic treatment for 28 to 35 days with Pradaxa 220mg once daily or enoxaparin 40mg once daily.
Results from this trial showed the composite total of VTE and all-cause death occurred in 7.7% of patients in the Pradaxa group vs. 8.8% of patients in the enoxaparin group.