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.
Venous thromboembolism (VTE) is the third most common cause of vascular death after myocardial infarction (heart attack) and stroke. 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.
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. Trial data also showed a 92 per cent reduction in the risk of recurrent blood clots versus placebo.
For more details, go to: http://www.boehringer-ingelheim.ca/en/news/press_releases/2014/4September201411.html