Boehringer Ingelheim has announced that Pradaxa (dabigatran etexilate) has been approved by the European Commission for the treatment and prevention of recurrence of deep vein thrombosis and pulmonary embolism. The US Food and Drug Administration (FDA) approved Pradaxa for deep vein thrombosis and pulmonary embolism patients earlier this year.
“We are delighted with the European Commission’s decision to approve Pradaxa for deep vein thrombosis and pulmonary embolism patients, confirming the well-studied efficacy and safety profile of Pradaxa, which has been established in a clinical trial programme in close to 10,000 patients for deep vein thrombosis and pulmonary embolism, and over 40,000 patients across different indications,” comments Klaus Dugi, chief medical officer, Boehringer Ingelheim.
The approval by the European Commission follows the positive opinion issued by the Committee for Medicinal Products for Human Use of the European Medicines Agency, and is based on results from three robust phase III clinical trials that demonstrated the efficacy of Pradaxa in the treatment and prevention of repeat deep vein thrombosis and pulmonary embolism 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 deep vein thrombosis or pulmonary embolism patients taking Pradaxa experienced significantly lower rates of bleeding than those taking warfarin, resulting in a favourable overall safety profile.