EU approves Pradaxa for DVT and Pulmonary Embolism - Boehringer

Boehringer Ingelheim announced that Pradaxa (dabigatran etexilate) has been approved by the European Commission on 6 June 2014 for the treatment and prevention of recurrence of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE). The FDA approved Pradaxa for DVT and PE patients earlier this year. DVT and PE can be very dangerous; almost one in three PE patients dies within three months and four out of 10 patients suffer a repeat blood clot within 10 years of the first.

Three robust phase III clinical trials that demonstrated the efficacy of Pradaxa in the treatment and prevention of repeat DVT and PE compared to warfarin. In a fourth trial, data showed a 92% reduction in the risk of recurrent blood clots in patients treated with Pradaxa compared to placebo. With regards to safety, 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. Pradaxa has the longest clinical trial experience in DVT and PE patients of any novel oral anticoagulant (NOAC).