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29 Aug 2013

FDA Accepts Boehringer Ingelheim's sNDA for Use of Dabigatran Etexilate Mesylate in Deep Vein Thrombosis and Pulmonary Embolism

Boehringer Ingelheim Pharmaceuticals Inc. has announced that FDA has accepted for review a 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. A DVT occurs when a blood clot develops in a deep vein, usually in the leg or pelvis, and either partially or totally blocks the flow of blood through the vein. A PE occurs when a DVT, or part of it, breaks off, and travels through the bloodstream to the lungs, blocking a vessel. This is considered a life-threatening condition. There are an estimated 900,000 VTE events per year in the US, approximately one-third of which result in death from PE. Further, 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, MD, senior vice president, Medicine & Regulatory Affairs, US Regional Medical Director, Boehringer Ingelheim Pharmaceuticals Inc. (BIPI). "We look forward to discussing with the FDA dabigatran's use in these two potentially life-threatening conditions."

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(TM) I and II, RE-MEDY((SM)) and RE-SONATE.

Pradaxa is currently approved by 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.

Prescribing experience with Pradaxa continues to grow with more than 6 million prescriptions for Pradaxa 150 mg and 75 mg filled for more than 800,000 NVAF patients in the US since its approval in October of 2010. Pradaxa is included on formularies that insure about 95% of covered lives in the US, through commercial and Medicare Part D plans. Pradaxa is also included in recommendations from three leading US cardiology guidelines for stroke prevention in AFib.

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