FDA Approves Anti-Coagulant Drug

(Yale School of Medicine/Wikimedia Commons)

The German pharmaceutical company Boehringer Ingelheim said the U.S. Food and Drug Administration (FDA) approved its drug Pradaxa (dabigatran etexilate), an oral-administered direct thrombin inhibitor to reduce the risk of stroke in patients with non-valvular atrial fibrillation (AF).  The company says this is the first such approval of a new oral anti-coagulant in the U.S. in more than 50 years.

FDA’s approval will make Pradaxa available to patients, with the 150 mg dose approved for most patients, except for those with severe renal impairment where the approved dose is 75 mg.

The approval is based on findings from a large AF clinical trial. The results demonstrated that dabigatran etexilate in a dosage of 150 mg reduced the risk of stroke and systemic embolism by 35 percent beyond the reduction achieved with warfarin, the longtime standard of care. The trial also showed reductions in life-threatening intracranial bleeding. The company says dabigatran etexilate does not require monitoring or related dose adjustments, is not affected by food, and no dose adjustment is required for many common co-medications in AF patients.

The clinical study was a global, phase 3, randomized trial of 18,113 patients enrolled in over 900 centers in 44 countries, investigating whether dabigatran etexilate (2 blinded doses) is as effective as well controlled warfarin. Patients were followed-up in the study for a median of 2 years with a minimum of 1 year follow-up.