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Boehringer Ingelheim. (6/6/14). "Press Release: Pradaxa Gains EU Approval for Treatment and Prevention of Recurrence of Deep Vein Thrombosis and Pulmonary Embolism [For media outside of the U.S., the UK & Canada only]". Ingelheim.

Region Region EU (European Union)
Organisations Organisation Boehringer Ingelheim (Group)
  Organisation 2 European Commission (EC)
  Group EU (govt)
Products Product Pradaxa®
  Product 2 warfarin (INN)
Persons Person Dugi, Klaus (Boehringer 201106 Corporate SVP Medicine)
  Person 2 Konstantinides, Stavros (Univ Mainz 201406 Professor)
     


For media outside of the U.S., the UK & Cananda only


> Pradaxa® is a simple treatment option that is as effective as warfarin with significantly lower bleeding rates, a major advance for DVT and PE patients 1-4

> EU approval follows recent U.S. FDA approval of Pradaxa® in DVT and PE and increases access to a treatment with proven protective benefits 1-5

> New approval makes Pradaxa® one of the most broadly indicated novel oral anticoagulants 1,6,7


Boehringer Ingelheim today announces that Pradaxa® (dabigatran etexilate) has been approved by the European Commission for the treatment and prevention of recurrence of deep vein thrombosis (DVT) and pulmonary embolism (PE).1 The U.S. Food and Drug Administration (FDA) approved Pradaxa® for DVT and PE patients earlier this year.5 DVT and PE can be very dangerous; almost one in three PE patients dies within three months and four out of 10 patients suffer a repeat blood clot within 10 years of the first.8,9

"We are delighted with the European Commission's decision to approve Pradaxa® for DVT and PE patients, confirming the well-studied efficacy and safety profile of Pradaxa®, which has been established in a clinical trial programme in close to 10,000 patients for DVT and PE, and over 40,000 patients across different indications," commented Professor Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim. "Access to this new treatment option is critical for patients as we know that PE as a consequence of a DVT is still the leading cause of preventable death in hospital."

The approval by the European Commission follows the positive opinion issued by the Committee for Medicinal Products for Human Use of the European Medicines Agency, and is based on results from three robust phase III clinical trials that demonstrated the efficacy of Pradaxa® in the treatment and prevention of repeat DVT and PE compared to warfarin.2-4 In a fourth trial, data showed a 92% reduction in the risk of recurrent blood clots in patients treated with Pradaxa® compared to placebo.4 With regards to safety, results showed that DVT or PE patients taking Pradaxa® experienced significantly lower rates of bleeding than those taking warfarin, resulting in a favourable overall safety profile.2-4 Pradaxa® has the longest clinical trial experience in DVT and PE patients of any novel oral anticoagulant (NOAC).4, 10-15

"This approval for dabigatran is a major advance for DVT and PE patients and their physicians," said Professor Dr. Stavros Konstantinides, Deputy Scientific Director of the Centre for Thrombosis and Haemostasis of Johannes Gutenberg University, Mainz, Germany. "Clinical trial results show that dabigatran has a favourable safety profile compared to warfarin, while offering similar efficacy for the treatment and prevention of recurrence of DVT and PE. The added benefits of convenience and a simple fixed dose regimen will appeal to patients and their physicians alike."

Pradaxa® is convenient for patients as it does not require routine dose monitoring, nor a mandatory dose change during the course of treatment. DVT and PE patients can start taking Pradaxa® in a simple fixed dose regimen after initial treatment with an injectable anticoagulant such as low-molecular-weight heparin (LMWH). 1

Clinical experience of Pradaxa® equates to over 2.9 million patient-years in all licensed indications worldwide. 16 Pradaxa® has already been available for more than six years and is approved in over 100 countries to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF).1,16 Pradaxa® 150mg bid is the only NOAC, study of which (RE-LY®) has shown a significant reduction in the incidence of both ischaemic and haemorrhagic strokes versus warfarin in patients with NVAF.17,18 Ischaemic strokes, which account for nine out of 10 strokes experienced by patients with AF, can have devastating consequences and are often fatal or severely disabling.19,20 RE-LY® was a global, phase III, PROBE (prospective, randomized, open-label with blinded endpoint evaluation) design trial comparing two fixed doses of the oral direct thrombin inhibitor Pradaxa® (110mg and 150mg bid) each administered in a blinded manner, with open label warfarin.17,18,21 Pradaxa® 110mg bid, which is indicated for certain patients, showed non-inferior efficacy versus warfarin for reducing risk of stroke.1,17,18 Pradaxa® is also approved for primary prevention of VTE (venous thromboembolism, the collective term for DVT and PE) in patients who have undergone elective total hip or total knee replacement surgery.1


NOTES TO THE EDITORS


About Pradaxa® (dabigatran etexilate)

Clinical experience of Pradaxa® (dabigatran etexilate) exceeds that of all other novel oral anticoagulants, equating to over 2.9 million patient-years in all licensed indications worldwide. Pradaxa® has been in the market for more than 6 years and is approved in over 100 countries.16

Currently approved indications for Pradaxa® are: 1

> Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and a risk factor for stroke
> Primary prevention of venous thromboembolic events in patients undergoing elective total hip replacement surgery
> Primary prevention of venous thromboembolic events in patients undergoing elective total knee replacement surgery
> Treatment of DVT and PE and the prevention of recurrent DVT and PE in adults

In the U.S. Pradaxa® is approved: 5

> To reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation
> For the treatment of deep vein thrombosis and pulmonary embolism in patients who have been treated with a parenteral anticoagulant for five to 10 days
> To reduce the risk of recurrence of deep vein thrombosis and pulmonary embolism in patients who have been previously treated

Additional registration processes for Pradaxa® in the treatment of DVT and PE, and prevention of recurrent DVT and PE, continue in individual countries worldwide.

Pradaxa®, a direct thrombin inhibitor (DTI), was the first widely approved drug in a new generation of direct oral anticoagulants, available to target a high unmet medical need in the prevention and treatment of acute and chronic thromboembolic diseases.22, 23 Potent antithrombotic effects are achieved with direct thrombin inhibitors by specifically blocking the activity of thrombin, the central enzyme in the process responsible for clot (thrombus) formation. 23 In contrast to vitamin-K antagonists, which variably act via different coagulation factors, Pradaxa® provides effective, predictable and reproducible anticoagulation with a low potential for drug-drug interactions and no drug-food interactions, without the need for routine coagulation monitoring or mandatory dose adjustment.22, 24


Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 142 affiliates and a total of more than 47,400 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.

Taking social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects, such as the initiative "Making more Health" and caring for the employees. Respect, equal opportunities and reconciling career and family form the foundation of the mutual cooperation. In everything it does, the company focuses on environmental protection and sustainability.

In 2013, Boehringer Ingelheim achieved net sales of about 14.1 billion euros. R&D expenditure corresponds to 19.5% of its net sales.


References

1. Pradaxa® European Summary of Product Characteristics 2014.  Approval 05 June 2014
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. Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis. Circulation. 2014;129:764-772.
4. Schulman S. et al. Extended Use of Dabigatran, Warfarin or Placebo in Venous Thromboembolism. N Engl J Med. 2013;368:709-18.
5. Pradaxa® Prescribing Information.  2014 Available at: http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing%20Information/PIs/Pradaxa/Pradaxa.pdf Last accessed: June 2014
6. Xarelto® European Summary of Product Characteristics 2014.
7. Eliquis® European Summary of Product Characteristics 2014.
8. Heit JA. et al. Predictors of Survival after Deep Vein Thrombosis and Pulmonary Embolism. Arch Intern Med. 1999;159:445-453.
9. Prandoni P. et al. The risk of recurrent venous thromboembolism after discontinuing anticoagulation in patients with acute proximal deep vein thrombosis or pulmonary embolism. A prospective cohort study in 1,626 patients. Haematologica. 2007;92(02):199-205.
10. The EINSTEIN Investigators. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med. 2010;363:2499-2510.
11. The EINSTEIN-PE Investigators. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism.
N Engl J Med. 2012;366(14):1287-1297.
12. Prins MH. et al, on behalf of the EINSTEIN Investigators. Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism: a pooled analysis of the EINSTEIN-DVT and PE randomized studies. Thromb J. 2013;11)1):21. 21. doi: 10.1186/1477-9560-11-21.
13. Agnelli G. et al. Oral apixaban for the treatment of acute venous thromboembolism. N Engl J Med. 2013;369:799-808.
14. Agnelli G. et al. Apixaban for extended treatment of venous thromboembolism. N Engl J Med. 2013;368:699-708
15. The Hokusai-VTE Investigators. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med. 2013;369:1406-1415.
16. Boehringer Ingelheim  Data on File.
17. Connolly SJ. et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361:1139-51.
18. Connolly SJ. et al. Newly identified events in the RE-LY trial. N Engl J Med. 2010;363:1875-6.
19. Gladstone DJ. et al. Potentially Preventable Strokes in High-Risk Patients With Atrial Fibrillation Who Are Not Adequately Anticoagulated. Stroke. 2009;40(1):235-40.
20. Andersen KK. et al. Hemorrhagic and ischemic strokes compared: stroke severity, mortality, and risk factors. Stroke. 2009;40(6):2068-72.
21. Ezekowitz M.D. et al. Rationale and design of RE-LY®: Randomized evaluation of long-term anticoagulant therapy, warfarin, compared with dabigatran. Am Heart J. 2009;157(5):805-10.
22. Stangier J. Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate. Clin Pharmacokinet.2008;47(5):285-95.
23. Di Nisio M, et al. Direct thrombin inhibitors. N Engl J Med. 2005;353:1028-40.
24. Stangier J, et al. Pharmacokinetic Profile of the Oral Direct Thrombin Inhibitor Dabigatran Etexilate in Healthy Volunteers and Patients Undergoing Total Hip Replacement. J Clin Pharmacol. 2005;45:555-63.


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Record changed: 2017-04-02

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