CHMP backs label change for Pradaxa

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for an update to the summary of product characteristics of Boehringer Ingelheim’s Pradaxa (dabigatran etexilate), for the treatment of patients with atrial fibrillation (AF).

CHMP recommends including new data that shows lower rates of major bleeding for uninterrupted Pradaxa 150 mg twice daily, compared to warfarin, in AF patients undergoing catheter ablation.

The updated label, if approved by the European Commission, will state that AF patients undergoing catheter ablation who take this dosage of Pradaxa will not need to stop taking their medication.