FDA approves Pradaxa for VTE - Boehringer

The FDA has approved Pradaxa (dabigatran etexilate mesylate), from Boehringer, for the treatment of Deep Venous Thrombosis (DVT) and Pulmonary Embolism (PE) - collectively referred to as Venous ThromboEmbolism (VTE) - in patients who have been treated with a parenteral anticoagulant for five to 10 days, and to reduce the risk of recurrent DVT and PE in patients who have been previously treated. The approval is based on results from four global Phase III studies.

The RE-COVER and RE-COVER II trials showed Pradaxa was non-inferior to warfarin in reducing DVT and PE after a median of 174 days of treatment, and was associated with lower rates of overall bleeding and a higher rate of any gastrointestinal (GI) bleeding (3.1% vs. 2.4%). RE-MEDYSM, which included patients who had been previously treated for an acute DVT and PE with anticoagulant therapy for three to 12 months, showed Pradaxa was non-inferior to warfarin in reducing DVT and PE after a median of 534 days of treatment, and was associated with lower rates of overall bleeding and a higher rate of any GI bleeding (3.1% vs. 2.2%).

RE-SONATE, which included patients who had been previously treated for an acute DVT and PE with anticoagulant therapy for six to 18 months, showed Pradaxa reduced the risk of DVT and PE recurrence by 92 percent compared to placebo after a median of 182 days of treatment: 0.4% vs. 5.6%. Pradaxa is also approved to reduce the risk of stroke in patients with non-valvular Atrial Fibrillation.