Boehringer Ingelheim gets FDA nod for Pradaxa

RIDGEFIELD, Conn. — Boehringer Ingelheim Pharmaceuticals announced that the Food and Drug Administration has approved Pradaxa (dabigatran etexilate mesylate). The drug is indicated for the treatment of deep venous thrombosis and pulmonary embolism in patients who have received 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, the company said.



It's estimated that there are 900,000 DVT and PE events per year in the United States, one-third of which result in death from PE. Collectively, DVT and PE are referred to as venous thromboembolism (VTE).



"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 Z. Goldhaber, M.D., director of Brigham and Women's Hospital's Thrombosis Research Group and professor of medicine at Harvard Medical School. "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."



A DVT happens when a blood clot blocks the normal flow of blood through a vein — usually located in the leg or pelvis — which can lead to swelling or pain. A PE occurs when a DVT (or part of it) breaks off and makes its way through the bloodstream to the lungs, blocking a vessel in the process.



"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," said Sabine Luik, M.D., SVP medicine and regulatoryaffairs, Boehringer Ingelheim Pharmaceuticals. "This approval is a testament to our commitment to evaluate Pradaxa in new areas of cardiovascular treatment in order to address evolving patient needs."