Boehringer Ingelheim has received US Food and Drug Administration approval for Pradaxa (dabigatran etexilate), an oral direct thrombin inhibitor that is used to reduce the risk of stroke in patients with non-valvular atrial fibrillation.
This decision marks the first approval of a new anticoagulant in the US for more than 50 years.
The approval makes Pradaxa available for a broad range of patients, as the 150mg dose is approved for all patients except those with severe renal impairment, where the approved dose is 75mg.
This approval is based on the results from largest atrial fibrillation trial, which showed that dabigatran etexilate 150mg significantly reduced the risk of stroke and systemic embolism by 35% more than the reduction achieved with warfarin.
Pradaxa 150mg also achieved reductions in life-threatening and intracranial bleeding.
Unlike warfarin, the standard of care, Pradaxa does not require related dose adjustments or monitoring, and is not affected by food.