Health Canada approves Pradaxa® for the treatment of venous thromboembolism events (deep vein thrombosis [DVT] and pulmonary embolism [PE]), and for the prevention of recurrent DVT and PE(1)

Venous thromboembolism is the third most common cause of vascular death after myocardial infarction and stroke²

BURLINGTON, ON, Sept. 4, 2014 /CNW/ - Boehringer Ingelheim (Canada) Ltd. announced today that on June 26, Health Canada approved Pradaxa® (dabigatran etexilate) for the treatment of venous thromboembolism events (deep vein thrombosis [DVT] and pulmonary embolism [PE]), and for the prevention of recurrent DVT and PE.¹

Venous thromboembolism (VTE) is the third most common cause of vascular death after myocardial infarction (heart attack) and stroke.² Deep vein thrombosis occurs when a blood clot forms deep in the veins (between the muscles).³ If left untreated, the blood clots can increase in size, break off and travel to the lungs, causing a PE.³

Health Canada's 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.^4,5,6 Trial data also showed a 92 per cent reduction in the risk of recurrent blood clots versus placebo.⁵ 

"Venous thromboembolism is a serious and potentially fatal condition. The risk of recurrence is highest in the first weeks and months following the initial episode⁷, which is why immediate diagnosis and initiation of effective treatment is so important during this early period," said Dr. Martina Flammer, Vice President, Medical and Regulatory Affairs, Boehringer Ingelheim (Canada) Ltd. "Long term recurrence of VTE poses a significant health risk - a fact that is often underestimated. VTE will recur in 30 per cent of patients over the decade following their first event.⁸ Pradaxa® is the only new oral anticoagulant that has been studied long-term in VTE against the current standard of care (warfarin) for the prevention of recurrence. This makes Pradaxa® an important new option for patients and their physicians."

About Pradaxa® (dabigatran etexilate)
Pradaxa® is a novel, reversible oral direct thrombin inhibitor.¹ It provides its anticoagulant effect by selectively blocking the activity of thrombin, the central enzyme in clot formation.¹

As the first novel oral anticoagulant to market, clinical experience with Pradaxa® continues to grow and equates to over three million patient-years in all licensed indications to date.⁹ Pradaxa® has the longest clinical trial experience in DVT and PE patients of any novel oral anticoagulant (NOAC).^5,10-15   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

Pradaxa® has been in the market for more than five years and is approved in over 100 countries.⁹

The efficacy and safety profile of Pradaxa® in its licensed indications is well documented in an extensive clinical trial programme.^4,5,16-21 In addition, the favourable benefit-risk profile of Pradaxa® is supported by safety assessments from regulatory authorities including the European Medicines Agency and the U.S. Food and Drug Administration (FDA).^22-24 Most recently in May 2014, in one of the largest real-world analyses of its kind, the FDA once again re-affirmed the favourable benefit/risk profile of Pradaxa® when it issued results from this study, including more than 134,000 patients.²⁵

Pradaxa® was first approved for the prevention of venous thromboembolic events (VTE) in patients who have undergone elective total hip replacement or total knee replacement surgery.¹ It was then approved for the prevention of stroke and systemic embolism in patients with atrial fibrillation (AF), in whom anticoagulation is appropriate.¹ To date, over 130,000 Canadians with AF have received Pradaxa® for stroke prevention.⁹

For dosing, side effects, warnings and precautions, please refer to the Pradaxa® Product Monograph:  http://www.boehringer-ingelheim.ca/content/dam/internet/opu/ca_EN/documents/humanhealth/product_monograph/PradaxaPMEN.pdf

About Boehringer Ingelheim (Canada) Ltd.
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.

The Canadian headquarters of Boehringer Ingelheim was established in 1972 in Montreal, Quebec and is now located in Burlington, Ontario. Boehringer Ingelheim employs more than 550 people across Canada.

For more information please visit www.boehringer-ingelheim.ca.

References

1. PRADAXA Product Monograph. June 24, 2014.
2. National Heart, Lung, and Blood Institute. Morbidity and mortality 1998 Chartbook on Cardiovascular, Lung and Blood Diseases. Bethesda, MD: Public Health Service, National Institutes of Health, NHLBI; October 1998.
3. Canadian Society for Vascular Surgery.  Deep Vein Thrombosis (DVT). http://canadianvascular.ca/index.php?m=73&page=374 (Accessed July 30, 2014)
4. Schulman S, et al. Dabigatran versus warfarin in the Treatment of Acute Venous Thromboembolism. N Engl J Med. 2009;361:2342–52.
5. Schulman S, et al. Extended Use of Dabigatran, Warfarin or Placebo in Venous Thromboembolism. N Engl J Med. 2013;368:709–18.
6. Schulman S, et al. Treatment of Acute Venous Thromboembolism with Dabigatran or Warfarin and Pooled Analysis. Circulation
7. Heit JA, et al. Heparin and warfarin anticoagulation intensity as predictors of recurrence after deep vein thrombosis or pulmonary embolism: a population-based cohort study. Blood. 2011 November ; 118(18): 4992-4999.
8. Heit JA, et al. Predictors of Recurrence After Deep Vein Thrombosis and Pulmonary Embolism: A Population-Based Cohort Study. Arch Intern Med. 2000;160:761-768.
9. Boehringer Ingelheim. Data on file.
10. Agnelli G, et al. Apixaban for Extended Treatment of Venous Thromboembolism. N Engl J Med 2013;368:699–708.
11. The EINSTEIN Investigators. Oral Rivaroxaban for Symptomatic Venous Thromboembolism. N Engl J Med 2010;363:2499–2510.
12. The EINSTEIN–PE Investigators. Oral Rivaroxaban for the Treatment of Symptomatic Pulmonary Embolism. N Engl J Med 2012;366:1287-97.
13. Prins MH. et al. Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism: a pooled analysis of the EINSTEIN-DVT and PE randomized studies. Thrombosis Journal 2013, 11:21.
14. Agnelli G. et al. Oral Apixaban for the Treatment of Acute Venous Thromboembolism. N Engl J Med 2013;369:799-808.
15. The Hokusai-VTE Investigators. Edoxaban versus Warfarin for the Treatment of Symptomatic Venous Thromboembolism. N Engl J Med 2013;369:1406-15.Connolly SJ, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361:1139–51.
16. Connolly SJ, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361:1139–51.
17. Eriksson BI. et al. Oral dabigatran etexilate vs. subcutaneous enoxaparin for the prevention of venous thromboembolism after total knee replacement: the RE-MODEL randomized trial. J Thromb Haemost. 2007;5:2178–85.
18. Eriksson BI. et al. Dabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trial. Lancet. 2007;370:949–56.
19. Eriksson BI. et al. Oral dabigatran versus enoxaparin for thromboprophylaxis after primary total hip arthroplasty (RE-NOVATE II*). A randomised, doubleblind, non-inferiority trial. Thromb Haemost. 2011;105(4):721-9.
20. Ginsberg JS. et al. Oral thrombin inhibitor dabigatran etexilate vs North American enoxaparin regimen for prevention of venous thromboembolism after knee arthroplasty surgery. J Arthoplasty. 2009;24(1)1–9.
21. Schulman S. et al. A Randomized Trial of Dabigatran Versus Warfarin in the Treatment of Acute Venous Thromboembolism  (RE-COVER II). Oral presentation from Session 332: Antithrombotic Therapy 1. Presented on 12 December at the American Society of Hematology (ASH) Annual Meeting 2011.
22. FDA Drug Safety Communication: Update on the risk for serious bleeding events with the anticoagulant Pradaxa (dabigatran) – 2 November 2012 http://www.fda.gov/Drugs/drugsafety/ucm326580.htm  Last accessed July 22, 2014..
23. European Medicines Agency Press release - 25 May 2012: EMA/337406/2012. European Medicines Agency updates patient and prescriber information for Pradaxa. http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/05/news_detail_001518.jsp. Last accessed 22 July 2014
24. FDA Safety Announcement.  http://www.fda.gov/Drugs/DrugSafety/ucm396470.htm (Accessed June 25, 2014)
25. FDA Drug Safety Communication: FDA study of Medicare patients finds risks lower for stroke and death but higher for gastrointestinal bleeding with Pradaxa (dabigatran) compared to warfarin – 13 May 2014. http://www.fda.gov/Drugs/DrugSafety/ucm396470.htm Last accessed May 2014.

SOURCE: Boehringer Ingelheim (Canada) Ltd.

please visit www.boehringer-ingelheim.ca