英文原文：FDA Approves Pradaxa® (dabigatran etexilate mesylate) for Treatment and Reduction in the Risk of Recurrence of Deep Venous Thrombosis and Pulmonary Embolism
The US Food and Drug Administration has approved German family-owned pharma major Boehringer Ingelheim’s Pradaxa (dabigatran etexilate mesylate) for additional indications, the firm’s US subsidiary announced today.
The FDA cleared Pradaxa for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for five to 10 days, and to reduce the risk of recurrent DVT and PE in patients who have been previously treated. DVT and PE are collectively referred to as venous thromboembolism (VTE). There are an estimated 900,000 DVT and PE events per year in the USA, around one-third of which result in death from PE.
Approved in 2010, Pradaxa generated sales of 612 million euros ($811 million) in the first half of 2013, up nearly 28%, for Boehringer, which has yet to report its 2013 financial results. The drug 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.
"Venous thromboembolism is the third most common cardiovascular disease after myocardial infarction and stroke. About one-third of patients with a DVT or PE will suffer a recurrence within 10 years," said Samuel Goldhaber, Director of Brigham and Women's Hospital's Thrombosis Research Group and Professor of Medicine, Harvard Medical School, adding: "Dabigatran has established efficacy and safety for stroke risk reduction in patients with non-valvular atrial fibrillation. This new FDA approval expands dabigatran's indications to include treatment and the reduction of the risk of recurrence of DVT and PE."
The approval is based on results from four global Phase III studies evaluating the efficacy and safety of Pradaxa in the treatment of DVT and PE. Three pivotal trials showed Pradaxa as non-inferior to warfarin in reduction of DVT and PE recurrence; a fourth pivotal trial showed Pradaxa reduced risk of recurrence by 92% compared to placebo.