Application submitted to the European Medicines Agency (EMA) for use of Pradaxa® in treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of recurrent DVT and PE

• Data show Pradaxa^® is as effective as the standard of care while offering safety advantages in the treatment of acute and the prevention of recurrent DVT and PE^1,2,3
• Pradaxa^® is already 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 or total knee replacement surgery⁴
• In-market experience with Pradaxa^® already spans over 1.6 million patient-years in all currently licensed indications in over 100 countries worldwide⁵

Ingelheim, Germany, June 24, 2013 – Boehringer Ingelheim today announced the submission of 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.*
 






Professor Klaus Dugi, 
Corporate Senior Vice President Medicine, 
Boehringer Ingelheim




“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.^1,2,3 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.^1,2,3 When compared to placebo, Pradaxa^® prevented nine out of ten episodes of recurrent DVT and PE.1 The results of the RE-COVER^®, RE-MEDYTM and RE-SONATE^® studies have been published in the New England Journal of Medicine.^1,2 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.⁴ In-market experience with Pradaxa^® already spans over 1.6 million patient-years in all currently licensed indications in over 100 countries worldwide.⁵
Pradaxa^® is currently not approved for the acute treatment or prevention of recurrent DVT and PE.

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References

1. Schulman S, et al. Extended Use of Dabigatran, Warfarin or Placebo in Venous Thromboembolism. N Engl J Med. 2013;368:709-18.
2. Schulman S, et al. Dabigatran versus Warfarin in the Treatment of Acute Venous Thromboembolism. N Engl J Med. 2009;361:2342-52.
3. Schulman S, et al. A Randomized Trial of Dabigatran Versus Warfarin in the Treatment of Acute Venous Thromboembolism (RE-COVER II). 2011;118: Oral presentation from Session 332: Antithrombotic Therapy 1. Presented on 12 December at the American Society of Hematology (ASH) Annual Meeting 2011.
4. Pradaxa® European Summary of Product Characteristics 2013.
5. Boehringer Ingelheim. Data on file.