Boehringer Ingelheim receives CHMP backing for new Pradaxa label update

Boehringer Ingelheim has announced that its anticoagulant Pradaxa has had a proposed label update recommended for European regulatory approval.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has endorsed an update to the European Summary of Product Characteristics (SmPC) of Pradaxa for the treatment of patients with atrial fibrillation, which would add recent data from the RE-CIRCUIT study to the label.

Findings from RE-CIRCUIT showed that uninterrupted twice-daily Pradaxa treatment was associated with lower rates of major bleeding compared to warfarin in atrial fibrillation patients undergoing catheter ablation.

As such, the updated label, if approved by the European Commission, will state that atrial fibrillation patients undergoing catheter ablation who take Pradaxa will not need to stop taking their medication.

Professor Jorg Kreuzer, vice-president of cardiovascular medicine at Boehringer Ingelheim, said: "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."

Pradaxa has now been in the market for more than eight years and has received approval in over 100 countries.

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