Boehringer Ingelheim today announced that the European Commission has granted marketing authorisation of the novel, oral direct thrombin inhibitor, Pradaxa (dabigatran etexilate) in all 27 EU member states.
It is anticipated that Pradaxa will be launched in Germany and the United Kingdom in the coming weeks.
Pradaxa is approved for the prevention of venous thromboembolic events in adults who have undergone elective total hip or total knee replacement surgery.
Dr Bengt Eriksson, University Hospital Sahlgrenska, 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).”
European approval of Pradaxa follows the submission of efficacy and safety data in February 2007 from the phase III RE-NOVATE and RE-MODEL studies led by Dr Eriksson. Pradaxa was demonstrated to be as effective and safe as injectable enoxaparin in preventing VTE and all-cause mortality following total hip replacement surgery and total knee replacement surgery in the trials. All test results were evaluated by an independent central adjudication committee blinded to the drug received by any patient.