EMA issues positive opinion for updated dabigatran summary of characteristics

Pradaxa dabigatran etexilate manufacture
Manufacturing dabigatran etexilate

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 dabigatran etexilate (Pradaxa, Boehringer Ingelheim) for the treatment of patients with atrial fibrillation (AF).

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

The updated SmPC, if approved by the European Commission, will state that AF patients undergoing catheter ablation who take dabigatran etexilate 150mg twice daily will not need to stop taking the medication.

The results from RE-CIRCUIT showed that uninterrupted dabigatran etexilate was associated with a significant reduction in major bleeding event (MBE) 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 (ACC; 17–19 March, Washington, DC, USA) and simultaneously published in the New England Journal of Medicine.

In addition, an Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation3 was published by leading professional organisations including the European Heart Rhythm Association (EHRA) this week in the Heart Rhythm journal. The statement supports a recommendation for performing AF ablation with uninterrupted dabigatran etexilate with the highest possible evidence level—a Class 1A recommendation.

“Optimal anticoagulation treatment during an AF ablation procedure is critically important as patients are at increased risk of complications for both bleeding and stroke. In the RE-CIRCUIT® trial, uninterrupted dabigatran etexilate was shown to be a much safer treatment choice with respect to major bleeding than warfarin,” comments Jörg Kreuzer, vice president Medicine, Therapeutic Area Cardiovascular, Boehringer Ingelheim. “The data recommended for inclusion in the dabigatran etexilate SmPC are a great piece of evidence on the benefits dabigatran etexilate 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.”


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