Pharmaprojects R&D Pipeline News Feed
EU approval for Boehringer Ingelheim’s Pradaxa
28 Mar 2008
Boehringer Ingelheim’s oral direct thrombin inhibitor, dabigatran etexilate (Pradaxa), has been granted EU approval for the prevention of venous thromboembolic events (VTE) in adults following orthopaedic surgery.
Patients undergoing knee or hip replacement face a high risk of VTE, as well as potentially fatal pulmonary embolism (PE). Recurrent VTE also carries a long-term risk of chronic venous insufficiency, adding to treatment cost and possible morbidity.
Pradaxa is currently in several large ongoing clinical trials, including the 27000-patient RE-VOLUTION trial assessing its use in patients with thromboembolic disease, and a Phase III trial (RE-LY) in 18114 patients for stroke prevention in atrial fibrillation. Andreas Barner of Boehringer Ingelheim said that the European approval of Pradaxa marked “an important advance and milestone in anticoagulation therapy”.
In terms of unmet medical need, the approval of Pradaxa now offers an effective and safe alternative to other thromboprophylactics for patients at risk of VTE. Launches in Germany and the UK are expected in the near future.
