Sanofi-Aventis is going to start a huge clinical trial looking at Multaq in patients with permanent atrial fibrillation which, if successful, could propel the much-touted new anti-arrhythmic towards blockbuster status.

Multaq (dronedarone) was approved in the USA last July to help reduce the risk of cardiovascular hospitalisation in patients with atrial fibrillation or atrial flutter. The drug brought in more than 20 million euros of US sales in the first quarter (it has now been launched in several European countries) but widening the indication would obviously bring in more money; permanent AF afflicts 50% of patients suffering from the condition.

Sanofi will initiate the Phase IIIb trial, named Pallas, which will involve 10,800 patients across 43 countries, in the third quarter. Its primary objective is to demonstrate a reduction in stroke, systemic arterial embolism, myocardial infarction or CV death or, secondly, CV hospitalisation or death from any cause among patients with permanent AF and additional risk factors.

The French drugmaker says the rationale behind the trial was based on findings from the landmark Athena trial, in which a trend towards reduction of CV hospitalisation and death was seen in patients classified as permanent. Sanofi quoted Stuart Connolly of the McMaster University in Canada, one of the study’s principal investigators, as saying that “a trial of major significance since no anti-arrhythmic drug has ever been shown to reduce major morbidity and mortality in permanent AF patients in a large-scale clinical trial”.