Positive CHMP opinion for SmPC of Pradaxa® for treatment of patients with atrial fibrillation

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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for an update to the European Summary of Product Characteristics (SmPC) of Pradaxa® (dabigatran etexilate) for the treatment of patients with atrial fibrillation (AF).

The CHMP recommends to include recent RE-CIRCUIT® data, which showed lower rates of major bleeding for uninterrupted Pradaxa® 150 mg twice daily compared to warfarin in AF patients undergoing catheter ablation.

If approved by the European Commission, the updated SmPC will state that AF patients undergoing catheter ablation who take Pradaxa® 150 mg twice daily will not need to stop taking their Pradaxa® medication.

The results from RE-CIRCUIT® showed that uninterrupted Pradaxa® was associated with a significant reduction in major bleeding event rate compared with INR-adjusted warfarin in the setting of ablation with no differences in the incidence of stroke or systemic embolism.

The data were originally presented earlier this year in a late-breaking session at the American College of Cardiology 66th Annual Scientific Session in Washington and simultaneously published in the New England Journal of Medicine.

In addition, an Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation was published by leading professional organisations including the European Heart Rhythm Association in the Heart Rhythm journal. 

The consensus from ablation experts around the world is that the data and worldwide experience regarding dabigatran now support a recommendation for performing AF ablation with uninterrupted Pradaxa® with the highest possible evidence level, a Class 1A recommendation. 

Professor Jörg Kreuzer, Vice President Medicine, Therapeutic Area Cardiovascular, Boehringer Ingelheim, said: “In the RE-CIRCUIT® trial, uninterrupted Pradaxa® was shown to be a much safer treatment choice with respect to major bleeding than warfarin.

“The data recommended for inclusion in the Pradaxa® SmPC are a great piece of evidence on the benefits Pradaxa® can offer patients with atrial fibrillation and their treating physicians. We are pleased that both the CHMP as well as international professional bodies recognise the significance of these data in their recommendations to physicians.”