Boehringer’s Pradaxa gains added indication in Europe

German family-owned pharma major Boehringer Ingelheim said today that its blood thinner Pradaxa (dabigatran etexilate) has been approved by the European Commission for the treatment and prevention of recurrence of deep vein thrombosis (DVT) and pulmonary embolism (PE).

The  US Food and Drug Administration approved Pradaxa for DVT and PE patients earlier this year. 2013 net sales of the drug increased by more than 16%, currency-adjusted (+8.8% in euro terms) to 1.2 billion euros ($1.64 billion).

"We are delighted with the European Commission’s decision to approve Pradaxa for DVT and PE patients, confirming the well-studied efficacy and safety profile of Pradaxa, which has been established in a clinical trial program in close to 10,000 patients for DVT and PE, and over 40,000 patients across different indications," commented Klaus Dugi, chief medical officer at Boehringer Ingelheim, adding: "Access to this new treatment option is critical for patients as we know that PE as a consequence of a DVT is still the leading cause of preventable death in hospital."