Treatment is reportedly the first new oral anticoagulant approved in the U.S. for over 50 years.

FDA has approved Boehringer Ingelheim’s oral direct thrombin inhibitor Pradaxa® (dabigatran etexilate) for use in reducing the risk of stroke in patients with nonvalvular atrial fibrillation (AF). The firm claims Pradaxa is the first new oral anticoagulant to reach the U.S. market in over 50 years. The approval is also the first worldwide for dabigatran etexilate for this indication.

U.S. clearance is based on data from the RE-LY® trial, designed as the largest AF trial ever completed at the time, BI states. The results showed that in comparison with warfarin therapy, Pradaxa 150 mg reduced the risk of stroke and systemic embolism by an extra 35%. Treatment with Pradaxa also requires no monitoring or related dose adjustments, is unaffected by food, and does not require dose adjustment as a result of co-treatment with other drugs AF patients may commonly require.

“Warfarin has been the standard therapy for stroke prevention in AF for many years,” explains Stuart Connolly, M.D., co-principal investigator for the RE-LY trial and director of the division of cardiology at McMaster University. “However, it is a very difficult treatment to use because of its interaction with various drugs and food types and the need for continuous monitoring to ensure that the drug is at the right therapeutic level. The approval of dabigatran etexilate provides for the first time an effective, flexible, and convenient treatment option in the U.S.”

Pradaxa was first approved across the European Union in 2008 for the prevention of venous thromboembolic events in adults who have undergone elective total hip or total knee replacement surgery. The drug is undergoing development for the prevention of secondary venous thromboembolism, the treatment of acute thromboembolism, and the secondary prevention of cardiac events in patients with acute coronary syndrome.

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