Pharmaceutical Business Review

Boehringer Ingelheim Pradaxa gets FDA nod

PBR Staff Writer Published 20 October 2010

Boehringer Ingelheim Pharmaceuticals' Pradaxa capsules (dabigatran etexilate) received the US Food and Drug Administration (FDA) approval for the prevention of stroke and blood clots in patients with abnormal heart rhythm (atrial fibrillation).

Pradaxa is an anticoagulant that acts by inhibiting thrombin, an enzyme in the blood that is involved in blood clotting.

A clinical trial comparing with the anticoagulant warfarin was designed to study the safety and efficacy of Pradaxa.

Reportedly, results from the study showed that patients taking Pradaxa had fewer strokes than those who took warfarin.

FDA Center for Drug Evaluation and Research Division of Cardiovascular and Renal Products director Norman Stockbridge said that unlike warfarin, which requires patients to undergo periodic monitoring with blood tests, such monitoring is not necessary for Pradaxa.