Boehringer Ingelheim announces development in Re-Volution programme

Boehringer Ingelheim has announced key progress in the development of the Re-Volution trial programme of dabigatran etexilate, its direct thrombin inhibitor.

Following the publication of data regarding the safety and efficacy of the compound to prevent venous thromboembolism in patients following knee or hip replacement surgery, the company has announced the start of a study in patients with acute coronary syndrome.

Boehringer Ingelheim submitted an application to register the compound early this year, with the drug to be marketed under the Pradaxa name.

In the Re-Deem study, patients with acute coronary syndrome who have experienced a myocardial infarction will be administered with four doses of dabigatran etexilate to evaluate its safety and indicators of efficacy.

Dr Andreas Barner, board member responsible for research, development and medicine at Boehringer Ingelheim, said: “We are very pleased to announce the increased scope of the already extensive clinical trial programme for our novel oral direct thrombin inhibitor, dabigatran etexilate.

“This underlines our commitment to improving the management of thrombotic disease by bringing to market a safe and effective alternative to current anticoagulants, which will be of benefit to both patients and physicians.”

He added that the new trial initiated by the firm shows the available potential of the new compound.

In September 2007, the Lancet published positive results of the Re-Novate study of dabigatran etexilate detailing its efficacy in extended thromboprophylaxis following total hip replacement surgery.