Things are not looking good for Sanofi-Aventis’ Multaq in the UK after preliminary recommendations from the NHS cost watchdog have rejected its use to treat atrial fibrillation.

Last month, Multaq (dronedarone) became the first new anti-arrhythmic to be approved in the European Union in the last decade, based on a clinical trial programme involving more than 7,000 patients, which showed that the drug reduced cardiovascular hospitalisations or death from any cause in patients with AF and atrial flutter.

However, its future in the UK is now looking shaky after the National Institute for Health and Clinical Excellence’s Appraisal Committee ruled against its use on the NHS. According to the Committee, while Multaq reduced AF recurrence compared with placebo it appeared to be less effective than other anti-arrhythmic drugs.

In addition, it said it had not been persuaded “that a reduction in the risk of all-cause mortality for Multaq compared with placebo and other anti-arrhythmic drugs had been demonstrated”, nor that the drug was associated with a lower stroke risk than other therapies on the market based on the evidence submitted.

And in terms of expense, it concluded that the use of Multaq as an alternative to the gold standard treatment amiodarone, class 1c agents, or sotalol for anti-arrhythmic treatment of AF could not be considered a cost-effective use of NHS resources.

While the recommendations are not final, Sanofi will likely have its work cut out in trying to persuade the Institute to change its position on the drug, and now has until the end of January to submit its comments on the ruling in time for a second appraisal hearing on February 24.