EU Approves Dabigatran for AF Indication

August 04, 2011

August 4, 2011 (Ingelheim, Germany) — Dabigatran etexilate (Pradaxa, Boehringer Ingelheim) has been officially approved in the EU for prevention of stroke and systemic embolism in patients with atrial fibrillation (AF), the company announced today [1]. The decision by the European Commission represents a label extension for the new oral anticoagulant, which is already available in the EU for prevention of venous thromboembolism (VTE) in the setting of hip- and knee-replacement surgery.

The approval follows the "positive opinion" handed down for the dabigatran AF indication in April by the European Medicines Agency (EMA), which is normally a prerequisite to pan-EU approval of a product within 67 days.

Boehringer Ingelheim will market the drug in Europe in the 110-mg and 150-mg strengths, as it does in Canada, with both dosages given twice daily as studied in the RE-LY trial, as covered extensively by heartwire . The 110-mg twice-daily dosage is intended for patients aged 80 years or older and anyone with an increased risk of bleeding.

Controversially, in the US the drug is approved for the AF/stroke indication at 150 mg twice daily for most patients but also at 75 mg twice daily--a dosage not studied in RE-LY--for patients with severe renal impairment.