The FDA will review a supplemental New Drug Application (sNDA) for Pradaxa (dabigatran etexilate mesylate) for its use in patients with venous thromboembolism (VTE), according to Boehringer Ingelheim Pharmaceuticals, Inc – the manufacturer of Pradaxa.
VTE, which is comprised of deep vein thrombosis (DVT) and pulmonary embolism (PE), is the third most common cardiovascular disorder after coronary artery disease and stroke.
Pradaxa is currently approved by the FDA to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF), and was the first oral anticoagulant approved by the FDA in more than 50 years for this indication.
The sNDA is based on results from four global Phase III studies evaluating the efficacy and safety of dabigatran in the treatment of this condition, specifically RE-COVER™ I and II, RE-MEDY(SM) and RE-SONATE®.
