Boehringer Ingelheim’s novel oral anticoagulant dabigatran etexilate (Pradaxa®) has been approved by the European Medicines Agency (EMA) for the treatment of patients with atrial fibrillation (AF) at risk of stroke.
This licence extension follows a recommendation by the EMA’s Committee for Medicinal Products for Human Use (CHMP) in April.
Dabigatran etexilate (150mg) is the only novel oral anticoagulant proven superior to well-controlled warfarin treatment (Median TTR 67%) in reducing stroke and systemic embolism in an intention-to-treat (ITT) analysis.
The ITT analysis represents the highest standard for analysing superiority in non-inferiority trials.
These groundbreaking results were shown in RE-LY®, a prospective, randomized, open-label with blinded endpoint evaluation (PROBE) trial designed to compare two fixed doses of the oral direct thrombin inhibitor dabigatran etexilate (110mg and 150mg bid), each administered in a blinded manner, with open label warfarin.
Dabigatran etexilate (110 mg) was shown to be as effective as warfarin. Both doses of dabigatran etexilate showed significantly lower intracranial bleeding compared to well-controlled warfarin.
Dabigatran etexilate does not require routine coagulation monitoring or dose adjustments, is not affected by food and has a low potential for drug-drug interactions.
Up to three million people worldwide suffer strokes related to AF each year, with one half of this population dying within one year.
Strokes due to AF tend to be severe, with an increased likelihood of death (20%), and disability (60%).
“It is a result of nearly 20 years of innovative research and development by our scientists,” said Boehringer’s Chairman, Andreas Barner.
“We will now ensure that this new breakthrough treatment is made available to physicians and AF patients throughout Europe as soon as possible.”
The CHMP approval is based on the results from the RE-LY® trial, the largest AF trial completed to date.
The data showed that dabigatran etexilate (150mg) significantly reduced the risk of stroke and systemic embolism by 35%, in addition to significantly lowering the risk of life-threatening and intracranial bleeding compared to well-controlled warfarin.