Pradaxa sNDA for DVT and PE accepted by FDA

The US Food and Drug Administration has accepted for review German independent drug major Boehringer Ingelheim’s supplemental New Drug Application (sNDA) for Pradaxa (dabigatran etexilate mesylate) for its use in patients with deep vein thrombosis (DVT) and pulmonary embolism (PE).

DVT and PE are collectively referred to as venous thromboembolism (VTE), which is the third most common cardiovascular disorder after coronary artery disease and stroke. There are an estimated 900,000 VTE events per year in the USA, around one-third of which result in death from PE. Furthermore, roughly one-third of people with VTE will have a recurrence within 10 years. The standard of care for patients with acute VTE is anticoagulation.

"Boehringer Ingelheim is committed to addressing the complex medical need of patients with deep vein thrombosis and pulmonary embolism," said Sabine Luik, senior vice president, medicine and regulatory affairs, US regional medical director, Boehringer Ingelheim Pharmaceuticals (BIPI). "We look forward to discussing with the FDA dabigatran's use in these two potentially life-threatening conditions," he added.