Boehringer Ingelheim’s Pradaxa (dabigatran etexilate) has become the first treatment in more than 50 years to be approved in Europe for the prevention of atrial fibrillation-related (AF) strokes.
The breakthrough oral anticoagulant has had its label extended in the EU for the prevention of stroke and systemic embolism (SSE) based on results from the RE-LY study.
Professor Andreas Barner, Chairman of the Board of Managing Directors at Boehringer, says Pradaxa’s approval is an “important milestone” after two decades of R&D.
Pradaxa was initially granted EU approval in 2008 for the prevention of blood clots in adults who have undergone elective total hip or knee replacement surgery.
People with AF are five-times more likely to suffer a stroke, resulting in up to three million individuals suffering strokes each year through the world.
More than 18,000 AF patients conducted in the RE-LY study. The 150mg dose – recommended for the majority of patients – was shown to reduce the risk of SSE by 35%, while also significantly reducing the risk of life-threatening and intracranial bleeding, compared to well-controlled warfarin.
The 110mg – specifically available for elderly patients aged 80 years or above – was shown to be non-inferior to warfarin in reducing the risk of SSE with a significantly lower rate of bleeding.
Professor Gregory Lip, Consultant Cardiologist & Professor of Cardiovascular Medicine, University of Birmingham Centre for Cardiovascular Sciences, says Pradaxa’s approval in Europe is a “major advance” to treat the condition.
“For the past 50 years physicians worldwide have been waiting for an alternative to vitamin K antagonist therapies, such as long time standard of care, warfarin,” he said.
Pradaxa has already been approved for the prevention of stroke in AF in the US, Canada, Japan, Australia and several other countries.