FDA Approves Pradaxa for Treatment of VTE

April 7, 2014—Boehringer Ingelheim Pharmaceuticals, Inc. (Ridgefield, CT) announced that the US Food and Drug Administration (FDA) has approved Pradaxa (dabigatran etexilate mesylate) for the treatment of venous thromboembolism (VTE), including both deep venous thrombosis (DVT) and pulmonary embolism (PE), in patients who have been treated with a parenteral anticoagulant for 5 to 10 days and to reduce the risk of recurrent DVT and PE. Pradaxa is also approved to reduce the risk of stroke in patients with nonvalvular atrial fibrillation.

In the company’s press release, Samuel Z. Goldhaber, MD, who is Director of Brigham and Women’s Hospital’s Thrombosis Research Group and Professor of Medicine at Harvard Medical School, commented, “Venous thromboembolism is the third most common cardiovascular disease after myocardial infarction and stroke. About one-third of patients with a DVT or PE will suffer a recurrence within 10 years. Dabigatran has established efficacy and safety for stroke risk reduction in patients with nonvalvular atrial fibrillation. This new FDA approval expands dabigatran’s indications to include treatment and the reduction of the risk of recurrence of DVT and PE.”

According to Boehringer Ingelheim, the FDA approval is based on results from four global phase III studies (RE-COVER I, RE-COVER II, RE-MEDY, and RE-SONATE) evaluating the efficacy and safety of Pradaxa for the treatment of DVT and PE.

As summarized by the company, the RE-COVER I and RE-COVER II trials included patients with DVT and PE who were treated with parenteral anticoagulant therapy for 5 to 10 days. These trials showed that Pradaxa was noninferior to warfarin in reducing DVT and PE after a median of 174 days of treatment and was associated with lower rates of overall bleeding but a higher rate of gastrointestinal (GI) bleeding (3.1% vs 2.4%).

The RE-MEDY trial included patients who had been previously treated for an acute DVT and PE with anticoagulant therapy for 3 to 12 months. The trial showed that Pradaxa was noninferior to warfarin in reducing DVT and PE after a median of 534 days of treatment and was associated with lower rates of overall bleeding but a higher rate of GI bleeding (3.1% vs 2.2%).

Finally, RE-SONATE aimed to study patients who had been previously treated for an acute DVT and PE with anticoagulant therapy for 6 to 18 months. The trial showed that Pradaxa reduced the risk of DVT and PE recurrence by 92% compared to placebo after a median of 182 days of treatment (0.4% vs 5.6%; hazard ratio [HR], 0.08; confidence interval [CI], 0.02–0.25). Pradaxa was associated with higher rates of any bleeding (10.5% vs 6.1%; HR, 1.77; CI, 1.2–2.61), clinically relevant nonmajor bleeding (5% vs 2%; HR, 2.54; CI 1.34–4.82), and GI bleeding (0.7% vs 0.3%) compared to placebo, reported Boehringer Ingelheim.