EMEA approves Boeh Ing's oral anticoagulant

German drug major Boehringer Ingelheim's oral direct thrombin inhibitor dabigatran etexilate has been approved by the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) for the prevention of venous thromboembolic events in patients who have undergone total hip or knee replacement surgery. A European Commission authorization to market the drug should now be granted within 67 days. Boehringer plans to market the compound under the brand name Pradaxa, with a planned launch in all 27 countries of the European Union.

The EMEA submission package included data from the RE-NOVATE study published in the September 15 issue of The Lancet (Marketletter September 24, 2007), demonstrating that dabigatran etexilate, administered once daily for a median of 33 days, was as effective as injectable enoxaparin in reducing the risk of venous thromboembolism after total hip replacement surgery, with a similar low bleeding profile.