The United States Food and Drug Administration has approved United States-based Boehringer Ingelheim Pharmaceuticals' Pradaxa (dabigatran etexilate mesylate), it was reported yesterday.

The product is intended for the prophylaxis of deep venous thrombosis and pulmonary embolism in patients who have undergone hip replacement surgery.

The approval is based on the results of two randomised, double-blind, phase III trials in patients undergoing total hip replacement, RE-NOVATE and RE-NOVATE II.

In RE-NOVATE I, 3,494 patients were randomised 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. In RE-NOVATE II, 2,055 patients were randomly assigned prophylactic treatment for 28 to 35 days with PRADAXA 220 mg once daily or enoxaparin 40 mg once daily.

Patients receiving PRADAXA were treated with a dose of 110 mg on the day of surgery and 220 mg daily thereafter. The results of RE-NOVATE showed patients taking PRADAXA 220 mg had a lower composite total of venous thromboembolism (VTE, which comprises DVT and PE) and all-cause death (6.0%) than those on enoxaparin 40 mg (6.7%).

In RE-NOVATE II, the composite total of VTE and all-cause death occurred in 7.7% of patients in the PRADAXA group compared with 8.8% of patients in the enoxaparin group.