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

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

References

1. Schulman S, et al. Dabigatran versus warfarin in the Treatment of Acute Venous Thromboembolism. N Engl J Med. 2009;361:2342–52.
2. Schulman S, et al. Extended Use of Dabigatran, Warfarin or Placebo in Venous Thromboembolism. N Engl J Med. 2013;368:709–18.
3. Schulman 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.
4. Heit JA, et al. Predictors of survival after deep vein thrombosis and pulmonary embolism. Arch Intern Med 1999;159:445–453.
5. BMJ Best Practice. VTE Prophylaxis. Available at: http://bestpractice.bmj.com/best-practice/monograph/1087.html. Last accessed: April 2014.
6. PRADAXA® 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.
7. The EINSTEIN Investigators. Oral Rivaroxaban for Symptomatic Venous Thromboembolism. N Engl J Med 2010;363:2499–2510.
8. Agnelli G, et al. Apixaban for Extended Treatment of Venous Thromboembolism. N Engl J Med 2013;368:699–708.
9. Boehringer Ingelheim. Data on file.
10. Connolly SJ, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361:1139–51.
11. Connolly SJ, et al. Newly identified events in the RE-LY trial. N Engl J Med. 2010;363:1875–6.
12. 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.
13. Andersen KK, et al. Hemorrhagic and ischemic strokes compared: stroke severity, mortality, and risk factors. Stroke. 2009;40(6):2068-72.