US FDA clears Boehringer Ingelheim’s Pradaxa for additional indications

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 FDS 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.