Boehringer’s Pradaxa gets FDA approval for DVT, PE treatment

German pharmaceutical firm Boehringer Ingelheim has received approval from the US Food and Drug Administration (FDA) for Pradaxa (dabigatran etexilate) to treat venous thromboembolism (VTE), which includes both deep venous thrombosis (DVT) and pulmonary embolism (PE).

The drug is indicated for these patients who have been treated with a parenteral (injectable) anticoagulant for five to 10 days, as well as to reduce the risk of recurrent DVT and PE in patients who have been previously treated.

Brigham and Women’s Hospital director of Thrombosis Research Group and Harvard Medical School professor of Medicine Samuel Goldhaber said 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," Goldhaber said.

"Dabigatran has an established efficacy and safety profile 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 robust Phase III clinical trials involving almost 10,000 patients that showed the efficacy of Pradaxa 150mg twice daily in the treatment and prevention of recurrent DVT and PE.

Image: FDA approves Boehringer’s Pradaxa for treatment of DVT and PE. Photo: courtesy of foto76/ freedigitalphotos.net