US FDA approves Pradaxa (dabigatran etexilate), a breakthrough treatment for stroke risk reduction in non-valvular atrial fibrillation.

The US Food and Drug Administration (FDA) has approved Pradaxa (dabigatran etexilate), Boehringer Ingelheim's novel, oral direct thrombin inhibitor for stroke risk reduction in patients with non-valvular atrial fibrillation marking the first approval of a new oral anticoagulant in the US. The approval makes Pradaxa available to a broad spectrum of patients, with the 150 mg bid dose approved for all patients except for a small subset with severe renal impairment (creatinine clearance 15-30 ml/min) where the approved dose is 75 mg bid. The approval is based on findings from RE-LY, the largest atrial fibrillation trial …