Boehringer Ingelheim's Pradaxa Approved in EU for DVT and PE Treatment

June 6, 2014—Boehringer Ingelheim announced that the company’s Pradaxa (dabigatran etexilate) has been approved by the European Commission for the treatment and prevention of recurrence of deep vein thrombosis (DVT) and pulmonary embolism (PE). Earlier this year, the company announced that the US Food and Drug Administration approved Pradaxa for DVT and PE patients.

According to Boehringer Ingelheim, the European approval follows a 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 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. Additionally, results showed that DVT or PE patients taking Pradaxa experienced significantly lower rates of bleeding than those taking warfarin, resulting in a favorable overall safety profile. 

The company stated that Pradaxa is convenient for patients because it does not require routine dose monitoring, nor a mandatory dose change during the course of treatment. DVT and PE patients can start taking Pradaxa in a simple fixed-dose regimen after initial treatment with an injectable anticoagulant such as low-molecular-weight heparin. 

In the company’s press release, Professor Stavros Konstantinides, MD, commented, “This approval for dabigatran is a major advance for DVT and PE patients and their physicians. Clinical trial results show that dabigatran has a favorable safety profile compared to warfarin, while offering similar efficacy for the treatment and prevention of recurrence of DVT and PE. The added benefits of convenience and a simple fixed-dose regimen will appeal to patients and their physicians alike.” Prof. Konstantinides is Deputy Scientific Director of the Center for Thrombosis and Hemostasis of Johannes Gutenberg University in Mainz, Germany.

Pradaxa has been available for more than 6 years and is approved in more than 100 countries with the following indications: to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, primary prevention of venous thromboembolic events in patients undergoing elective total hip replacement surgery, primary prevention of venous thromboembolic events in patients undergoing elective total knee replacement surgery, and treatment of DVT and PE and the prevention of recurrent DVT and PE in adults.

In the United States, Pradaxa is approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, to treat DVT and PE in patients who have been treated with a parenteral anticoagulant for 5 to 10 days, and to reduce the risk of recurrence of DVT and PE in patients who have been previously treated.

Boehringer Ingelheim advised that Pradaxa is a direct thrombin inhibitor and is one of a new generation of direct oral anticoagulants that are available to target a high unmet medical need in the prevention and treatment of acute and chronic thromboembolic diseases. Antithrombotic effects are achieved with direct thrombin inhibitors by specifically blocking the activity of thrombin, the central enzyme in the process responsible for thrombus formation. In contrast to vitamin K antagonists, which variably act via different coagulation factors, Pradaxa provides effective, predictable, and reproducible anticoagulation with a low potential for drug-drug interactions and no drug-food interactions and without the need for routine coagulation monitoring or mandatory dose adjustment, stated the company.