Novel oral anticoagulant Pradaxa wins EC approval
The European Commission has granted marketing authorisation of the novel, oral direct thrombin inhibitor, Pradaxa (dabigatran etexilate) in all 27 EU member states.
The European Commission has granted marketing authorisation of the novel, oral direct thrombin inhibitor, Pradaxa (dabigatran etexilate) in all 27 EU member states.
Pradaxa from Boehringer Ingelheim is approved for the prevention of venous thromboembolic events in adults who have undergone elective total hip or total knee replacement surgery.
Boehringer Ingelheim board member Dr Andreas Barner, who is responsible for research, development and medicine said: "This first licence for our novel oral anticoagulant Pradaxa marks an important advance and milestone in anticoagulation therapy and the prevention of potentially fatal thrombi (blood clots). In addition, we remain confident in the potential for Pradaxa to satisfy the unmet medical needs of even more patients and physicians in the future as we continue to invest in our extensive RE-VOLUTIONTM clinical trial programme investigating Pradaxa across four further therapeutic areas."
Dr Bengt Eriksson, principal investigator of RE-NOVATETM and RE-MODELTM studies, Department of Orthopaedic Surgery, University Hospital Sahlgrenska/ “stra, Gothenburg, Sweden said:
"The risk of a potentially life-threatening thrombosis is a major concern following major orthopaedic surgery. For many years, there has been a need for an effective oral anticoagulant with a good safety profile to enable convenient thromboprophylaxis management in and out of the hospital environment. Now, following the approval of Pradaxa, we will have an attractive alternative to other thromboprophylaxis regimens to protect our patients from venous thromboembolism (VTE)."
Pradaxa prevents thrombus formation by specifically and selectively inhibiting thrombin, the central and essential enzyme that enables the conversion of fibrinogen into fibrin during the coagulation cascade, and therefore prevents the development of a thrombus.(1,2)
Boehringer Ingelheim continues to evaluate the efficacy and safety of Pradaxa in a range of thromboembolic disease conditions. RE-VOLUTION is an extensive clinical trial programme involving more than 34,000 patients worldwide. Recent progress announcements include the early enrolment completion of 18,114 patients in RE-LY, the largest atrial fibrillation outcomes trial to date. Other ongoing studies are evaluating the efficacy and safety of Pradaxa in the treatment of acute VTE, the secondary prevention of VTE and prevention of cardiac events in patients with acute coronary syndrome.
Release of the drug is imminent in Germany and the UK.