Boehringer Ingelheim has announced the approval of the U.S. Food and Drug Administration (FDA) of Pradaxa (dabigatran etexilate mesylate) for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) recurrence.
Pradaxa is currently approved for the reduction of risk of stroke in patients with non-valvular atrial fibrillation (NVAF). The FDA newly approved Pradaxa to treat patients with DVT and PE who have been treated with a parenteral anticoagulant for five to 10 days. The drug is also indicated in the reduction of risk of recurrent DVT and PE in patients who have previously undergone treatment.
Together, DVT and PE are collectively called venous thromboembolism (VTE). There are approximately 900,000 PE and DVT events every year in the U.S., about one third of which result in death from pulmonary embolism.
Samuel Z. Goldhaber, Director of Brigham and Women’s Hospital’s Thrombosis Research Group and Professor of Medicine at Harvard Medical School, 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. 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 was based on results from four global Phase III trials assessing safety and efficacy of PRADAXA for DVT and PE treatment.
Sabine Luik, M.D., SVP of Medicine & Regulatory Affairs at Boehringer Ingelheim, said, “Deep vein thrombosis and pulmonary embolism can be life-threatening. Boehringer Ingelheim is pleased that patients will now have a new and efficacious therapeutic option for this complex condition. This approval is a testament to our commitment to evaluate PRADAXA in new areas of cardiovascular treatment, in order to address evolving patient needs.”