FDA approves Pradaxa® for treatment and reduction in risk of recurrent deep vein thrombosis (DVT) and pulmonary embolism (PE)

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• New indications for Pradaxa® offer U.S. DVT and PE patients a simple treatment option that is as effective as warfarin with significantly less bleedings1,2,3
• Almost one in three DVT or PE patients die within three months; DVT-related PE is the leading cause of preventable death in hospital4,5
• FDA approval broadens use of Pradaxa® in the U.S.; Pradaxa® is already approved for stroke prevention in patients with atrial fibrillation6

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

Ingelheim, Germany, April 8, 2014 – Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has approved Pradaxa® (dabigatran etexilate) for the treatment of DVT and PE in patients who have been treated with a parenteral (injectable) anticoagulant for five to 10 days, and to reduce the risk of recurrent DVT and PE in patients who have been previously treated.

"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, Harvard Medical School. "Dabigatran has an established efficacy and safety profile 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 FDA approval is based on results from four robust phase III clinical trials involving almost 10,000 patients that demonstrated the efficacy of Pradaxa® 150 mg twice daily in the treatment and prevention of recurrent DVT and PE.1,2,3 Trial data also showed a 92% reduction in the risk of recurrent blood clots versus placebo.2 Results showed that DVT or PE patients taking Pradaxa® experienced significantly lower rates of bleeding, resulting in a favourable overall safety profile.3

Pradaxa® has the longest clinical trial experience in DVT and PE patients of any novel oral anticoagulant (NOAC). Pradaxa® simplifies treatment for patients and physicians as it is the only approved oral anticoagulant which does not require a mandatory dose change during the standard 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).2,6,7,8

"Boehringer Ingelheim is pleased that patients in the U.S. will now have access to a new and convenient treatment option for these life-threatening and complex conditions," said Professor Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim. "The approval of these new indications represents another significant landmark for Pradaxa®, and this positive news further strengthens our commitment to optimising patient management in the field of anticoagulation."

Clinical experience of Pradaxa® exceeds that of all other NOACs, equating to over 2.7 million patient-years in all licensed indications worldwide.9 Already approved by the FDA to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF)6, Pradaxa® is the only NOAC to have shown in its clinical trial (RE-LY®) a significant reduction in the incidence of both ischaemic and haemorrhagic strokes in patients with NVAF compared to warfarin.10,11 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.12,13

For more information on Pradaxa® DVT and PE clinical trials, please visit: http://www.newshome.com/dvt-pe.aspx

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 2.7 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.9 Currently approved indications for Pradaxa® are:

  • 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 surgery14

In the U.S. Pradaxa® is approved:

  • 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 continue in individual countries world-wide.

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.15,16 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.17 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 dose adjustment.15,17

About Boehringer Ingelheim
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. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.

Social responsibility is a central element of Boehringer Ingelheim's culture. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim’s endeavours.

In 2012, Boehringer Ingelheim achieved net sales of about 14.7 billion euro. R&D expenditure in the business area Prescription Medicines corresponds to 22.5% of its net sales.

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References
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2Schulman S, et al. Extended Use of Dabigatran, Warfarin or Placebo in Venous Thromboembolism. N Engl J Med. 2013;368:709–18.
3Schulman S, et al. Treatment of Acute Venous Thromboembolism with Dabigatran or Warfarin and Pooled Analysis. Circulation published online before print December 16, 2013, doi:10.1161.
4Heit JA, et al. Predictors of survival after deep vein thrombosis and pulmonary embolism. Arch Intern Med 1999;159:445–453.
5BMJ Best Practice. VTE Prophylaxis. Available at: http://bestpractice.bmj.com/best-practice/monograph/1087.html. Last accessed: April 2014.
6PRADAXA® Prescribing Information, 2013. Available at: http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing%20Information/PIs/Pradaxa/Pradaxa.pdf. Last accessed: April 2014.
7The EINSTEIN Investigators. Oral Rivaroxaban for Symptomatic Venous Thromboembolism. N Engl J Med 2010;363:2499–2510.
8Agnelli G, et al. Apixaban for Extended Treatment of Venous Thromboembolism. N Engl J Med 2013;368:699–708.
9Boehringer Ingelheim. Data on file.
10Connolly SJ, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361:1139–51.
11Connolly SJ, et al. Newly identified events in the RE-LY trial. N Engl J Med. 2010;363:1875–6.
12Gladstone DJ, et al. Potentially Preventable Strokes in High-Risk Patients With Atrial Fibrillation Who Are Not Adequately Anticoagulated. Stroke. 2009;40(1):235–40.
13Andersen KK, et al. Hemorrhagic and ischemic strokes compared: stroke severity, mortality, and risk factors. Stroke. 2009;40(6):2068-72.
14Pradaxa® European Summary of Product Characteristics, 2014.
15Stangier J. Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate. Clin Pharmacokinet. 2008;47(5):285–95.
16Di Nisio M, et al. Direct thrombin inhibitors. N Engl J Med. 2005;353:1028–40.
17Stangier 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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