Boehringer Ingelheim anticoagulant receives EC approval

Boehringer Ingelheim has announced that its novel orally-administered anticoagulant Pradaxa (dabigatran etexilate) has been approved by the European Commission (EC)

The direct thrombin inhibitor has been approved in all EU member states and is due to be launched in the UK shortly.

Approval of the compound followed the submission of clinical trial data from the Re-Novate and Re-Model studies in February 2007.

Pradaxa is approved as a treatment for patients who have undergone elective total knee or total hip replacement surgery for the prevention of venous thromboembolism.

Dr Bengt Eriksson, of the Department of Orthopaedic Surgery at University Hospital Sahlgrenska Ostra, 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.”

He added that the approval of Pradaxa offers an attractive treatment alternative to existing thromboprophylaxis regimens to protect patients from venous thromboembolic events.

In January 2008, Boehringer Ingelheim confirmed that it was expanding its testing of Pradaxa to include patients with acute coronary syndrome.