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.
SOURCE Boehringer Ingelheim (Canada) Ltd.
For further information: please visit www.boehringer-ingelheim.ca
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