Dabigatran etexilate recommended for approval in atrial fibrillation for stroke prevention in Europe
Ingelheim, Germany, 15. April 2011 – Boehringer Ingelheim's novel oral anticoagulant dabigatran etexilate (to be marketed under the trademark Pradaxa®), 1 received a positive opinion from the European Medicines Agency's (EMA) medicinal committee today. 2 This positive opinion is a decisive step in making the breakthrough therapy available to millions of patients with atrial fibrillation (AF) at risk of stroke in the European Union.
The Committee for Medicinal Products for Human Use (CHMP) has recommended approval of dabigatran etexilate in the member states of the EU for the prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation with one or more risk factors *. 2