The current approval is the second approval of this new oral anticoagulant following the recent marketing authorisation by the US Food and Drug Administration (FDA).
The approval is supported by the findings from RE-LY, the AF trial which demonstrated that dabigatran etexilate 150mg reduced the risk of stroke and systemic embolism by 35% beyond the reduction achieved with warfarin.
Co-principal investigator of RE-LY Stuart Connolly said that Dabigatran etexilate is a significant advance in medicine.
"It is really great to finally have a safer and more effective alternative for patients with AF, which is easier to use. The approval of dabigatran etexilate will transform the way we treat and manage patients with atrial fibrillation at risk of stroke," Connolly said.
Boehringer Ingelheim Medicine corporate senior vice president Klaus Dugi said that the approvals of dabigatran etexilate for stroke prevention in AF in North America are good news for patients and physicians, who now have access to a novel agent that has the potential to change the treatment paradigm in this indication.