Breakthrough therapy PRADAXA® (dabigatran etexilate) first drug in 50 years to gain approval for stroke prevention in atrial fibrillation in Europe
Ingelheim, Germany, 4 August 2011 – The European Commission (EC) today approved Boehringer Ingelheim’s breakthrough oral anticoagulant, Pradaxa® 1 (dabigatran etexilate 2) for the prevention of stroke in patients with atrial fibrillation (AF) at risk of stroke. This EU label extension means that, for the first time in over 50 years, millions of AF patients across Europe will have access to a new treatment for the prevention of AF-related strokes which is effective and convenient 3,4, and has demonstrated a good safety profile.
The EC has approved the use of dabigatran etexilate in the EU for the prevention of stroke and systemic embolism in adult patients with non-valvular AF with one or more risk factors. While overall the 150mg bid dose is recommended for the majority of patients, the 110mg bid dose is specifically available for elderly patients aged 80 years or above, for patients at increased risk of bleeding and for patients who are co-administered with dabigatran etexilate and the calcium channel blocker verapamil.