Boehringer Ingelheim has submitted an application to the European Medicines Agency (EMA) for use of Pradaxa (dabigatran etexilate) for the treatment of acute deep vein thrombosis (DVT) and pulmonary embolism (PE) and the prevention of recurrent DVT and PE.
“Given the risk of potentially fatal consequences and recurrences of a deep vein thrombosis or pulmonary embolism, there is a need for safe and effective therapies to improve outcomes for patients,” said professor Klaus Dugi, corporate senior vice president medicine, Boehringer Ingelheim. “Our studies have demonstrated that Pradaxa offers an effective treatment with significant safety benefits compared to warfarin both for acute treatment as well as in the long-term prevention of recurrent events. We are convinced that this treatment option can provide benefits to patients with acute DVT or PE, or those at risk of recurrent DVT and PE.”
The EMA submission is based on the results of four global phase III studies investigating the efficacy and safety of Pradaxa in the treatment of acute DVT and PE and in secondary prevention of recurrent DVT and PE. In these studies, Pradaxa was proven to be as effective as warfarin, with lower rates of clinically relevant bleeding (which includes major bleeding) and total bleeding for patients with DVT or PE. When compared to placebo, Pradaxa prevented nine out of ten episodes of recurrent DVT and PE. The results of the RE-COVER, RE-MEDY and RE-SONATE studies have been published in the New England Journal of Medicine. All studies are part of the extensive RE-VOLUTION clinical trial programme investigating Pradaxa in multiple indications.
Pradaxa is already widely approved for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and for the primary prevention of venous thromboembolic events in patients undergoing elective total hip replacement and total knee replacement surgery. In-market experience with Pradaxa already spans over 1.6 million patient-years in all currently licensed indications in over 100 countries worldwide.
Pradaxa is currently not approved for the acute treatment or prevention of recurrent DVT and PE.
DVT, and its potentially fatal acute complication PE, are collectively termed venous thromboembolism (VTE), estimated to be the third most common cardiovascular disorder after coronary heart disease and stroke. A venous thrombosis is a blood clot (thrombus) that forms within a vein. Most often, it develops in the deep veins of the leg or pelvis and is known as deep vein thrombosis. An embolism occurs if the clot, or a part of it, breaks off from the site of formation and travels through the circulatory system. If the clot lodges in the lung a potentially fatal condition, pulmonary embolism, occurs.
Over 750,000 DVT or PE events are estimated to occur annually in six major EU countries (France, Germany, Italy, Spain, Sweden, UK), and over 900,000 events occur annually in the US. Figures for the six European countries show that venous thrombotic events kill more people than AIDS, breast cancer, prostate cancer, and traffic accidents combined. The risk of experiencing a recurrent DVT or PE event increases cumulatively in patients who are not treated with standard therapy, up to 40% after 10 years.
The RE-VOLUTION trial programme encompasses studies in primary DVT prevention, acute DVT and PE treatment, secondary DVT and PE prevention, stroke prevention in atrial fibrillation.
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 140 affiliates and more than 46,000 employees.