Pradaxa Gets FDA Approval for New Indication

The Food and Drug Administration (FDA) has approved Pradaxa (dabigatran etexilate mesylate; Boehringer Ingelheim) for the prophylaxis of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients who have undergone hip replacement surgery. This marks the fourth FDA approval for the anticoagulant.

The FDA approval was based on the results of two Phase 3 trials, RE-NOVATE and RE-NOVATE II. Patients who had undergone hip replacement surgery received Pradaxa 75mg after surgery followed by 150mg daily (RE-NOVATE), Pradaxa 110mg after surgery followed by 220mg daily (RE-NOVATE and RE-NOVATE II) or enoxaparin SC 40mg once daily initiated the evening before surgery (RE-NOVATE and RE-NOVATE II) for the prophylaxis of DVT and PE. Overall, in RE-NOVATE and RE-NOVATE II, the median treatment duration was 33 days for both Pradaxa and enoxaparin.

The results of RE-NOVATE showed patients taking Pradaxa 220mg had a lower composite endpoint of confirmed VTE (proximal or distal DVT on venogram, confirmed symptomatic DVT, or confirmed PE) and all-cause death (6.0%) than those on enoxaparin 40mg (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 vs. 8.8% of patients in the enoxaparin group. 

In addition to this new approval, Pradaxa, a direct thrombin inhibitor, is also indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation; for the treatment of DVT and PE in patients who have been treated with a parenteral anticoagulant for 5–10 days; and to reduce the risk of recurrent DVT/PE in patients who have been previously treated.

For more information visit Boehringer-Ingelheim.com.