Boehringer Ingelheim’s Pradaxa receives NICE recommendation

Boehringer Ingelheim has been granted a recommendation from the UK's National Institute for Health and Clinical Excellence (NICE) for its atrial fibrillation therapy Pradaxa (dabigatran).

The regulatory body has issued final guidance endorsing the drug as a treatment for the prevention of stroke and systemic embolism in people with atrial fibrillation, based on positive data from clinical trials.

NICE also advised that any decision about whether to start treatment with Pradaxa should be taken after a discussion of its potential risks compared to warfarin, as well as the patient's current level of international normalised ratio control.

Boehringer Ingelheim's drug is also authorised for use among UK atrial fibrillation patients aged over 65 with diabetes, coronary heart disease or hypertension.

Professor Carole Longson, director of the NICE Health Technology Evaluation Centre, said: "Because dabigatran does not require frequent blood tests to monitor treatment it represents a useful alternative option for people with atrial fibrillation."

To date, Pradaxa has been approved for the prevention of stroke among atrial fibrillation patients in more than 50 countries.