CHMP recommends Pradaxa for DVT and PE - Boehringer

The CHMP of the European Medicines Agency has issued a positive opinion recommending approval of Pradaxa (dabigatran etexilate), from Boehringer, in the treatment of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE) and the prevention of recurrent DVT and PE in adults. The CHMP positive opinion is based on results from four robust Phase III clinical trials involving almost 10,000 patients that demonstrated the efficacy of Pradaxa in the treatment and prevention of repeat DVT and PE compared to warfarin. Data also show a 92% reduction in the risk of recurrent blood clots versus placebo. Results showed that DVT or PE patients taking Pradaxa experienced significantly lower rates of bleeding than those taking warfarin, resulting in a favourable overall safety profile. The FDA approved Pradaxa for DVT and PE patients earlier this month.