Boehringer Ingelheim has announced that it’s breakthrough novel oral anticoagulant Pradaxa (dabigatran etexilate) was awarded the prestigious Prix Galien in Canada.
According to a press release, at a Gala Ceremony during the Tenth Annual Canadian Health Research Awards Ceremony in Ottawa, Pradaxa (Pradax in Canada) was recognised as the most innovative Canadian product in 2011. Pradaxa has now received this award for the second time, after winning the German Prix Galien in 2010, in the Primary Care category. The Prix Galien is awarded for new drugs representing a significant advance in pharmaceutical research.
“We are proud that Pradaxa has been awarded the Canadian Prix Galien,” says Prof. Dr Klaus Dugi, corporate senior vice president Medicine at Boehringer Ingelheim. “The decision by the jury underlines the outstanding innovation Pradaxa brings for patients and doctors, providing a much needed advance in stroke prevention in atrial fibrillation, an area of high therapeutic need.”
The approval of Pradaxa in prevention of stroke and systemic embolism in adults with non-valvular atrial fibrillation (SPAF) was based on data from the landmark RE-LY trial (Randomized Evaluation of Long term anticoagulant therapY), a global, phase III trial of 18,113 patients, enrolled in over 950 centres in 44 countries.
“Pradaxa is a significant advance in medicine. We have been waiting a long time for an alternative to warfarin. Pradaxa provides superior and clinically significant stroke prevention in the high dose while maintaining an equal level of safety when compared to warfarin,” says Dr Stuart Connolly, director, Division of Cardiology at The Population Health Research Institute, McMaster University in Hamilton, Canada. “In addition, it does not require regular blood tests, constant dose adjustments or food restrictions, which makes it very convenient for patients.”
Pradaxa is an oral anticoagulant for the prevention of stroke and systemic embolism in adults with non-valvular atrial fibrillation (SPAF) and the primary prevention of venous thromboembolism (VTE) in patients undergoing elective total hip and knee replacement surgery. The approval of Pradaxa was welcomed by the medical community and patients because it was the first new oral anticoagulant approved in decades in countries all over the world.
AF is the most common type of arrhythmia or irregular heartbeat, affecting around 1% of the total population with one in four adults over 40 developing the condition in their lifetime. People with AF are more likely to experience blood clots, which increases the risk of stroke by five-fold. Up to three million people worldwide suffer strokes related to AF each year.
Dabigatran etexilate is at the forefront of a new generation of oral anticoagulants/direct thrombin inhibitors (DTIs)10 targeting a high unmet medical need in the prevention and treatment of acute and chronic thromboembolic diseases.
Potent antithrombotic effects are achieved with direct thrombin inhibitors by specifically blocking the activity of thrombin (both free and clot-bound), the central enzyme in the process responsible for clot (thrombus) formation. In contrast to vitamin-K antagonists, which variably act via different coagulation factors, dabigatran etexilate provides effective, predictable and consistent anticoagulation with a low potential for drug-drug interactions and no drug-food interactions, without the need for routine coagulation monitoring or dose adjustment.
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