Friday, July 08, 2011

Sanofi ends late-stage trial of Multaq due to "significant" rise in cardiovascular events | FirstWord Pharma

Sanofi announced Thursday the termination of a Phase IIIb study of Multaq (dronedarone) in patients with permanent atrial fibrillation (AF) after the trial's data monitoring committee observed a "significant increase" in cardiovascular events among those given the anti-arrhythmic drug. Stuart Connolly, co-principal investigator on the study, said it was disappointing "to discover that the hypothesis that [Multaq] would improve major outcomes for this high risk patient population has been refuted."

The randomised PALLAS trial, which involved 3149 patients aged over 65 with co-morbid conditions, compared the efficacy of Multaq twice-daily to placebo. The company noted that 70 percent of the study population had permanent AF for over two years. The trial's two composite co-primary endpoints were major cardiovascular events, including stroke, systemic arterial embolism, myocardial infarction or cardiovascular death, and cardiovascular hospitalisation or death from any cause.

The company indicated that the decision to end the trial wasn't "related to any hepatic adverse event" associated with Multaq. In January, Sanofi confirmed that two patients treated with the drug had suffered liver failure that required transplantation. Although no causal link has been established with the drug, the FDA has added a new warning about the risk for liver damage to the label of the product, while European regulators are reviewing Multaq's benefit-risk profile following the reports of liver injury.

Sanofi noted that the benefit-risk of Multaq "remains unchanged" in patients with the non-permanent form of the disease. Multaq is currently approved in the EU for adults with non-permanent AF, while in the US, Multaq is indicated to reduce the risk of cardiovascular hospitalisation in patients with paroxysmal or persistent AF or atrial flutter.

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