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The FDA announced that it launched a review of Sanofi’s Multaq (dronedarone) after a late-stage study involving patients with permanent atrial fibrillation (AF) suggested an increased risk of death, stroke and hospitalisation from heart failure among patients given the drug. The European Medicines Agency also indicated that it was expanding an ongoing review of the risks and benefits of Multaq, and Health Canada also launched its own review earlier this month.

"A critical question is whether and how the unfavourable results" of the PALLAS trial, which has since been halted, apply to patients with other types of AF for which the drug is approved, the FDA said. However, the agency noted that the study results are preliminary and that it would wait until final data are available before taking any regulatory action. Moreover, the FDA indicated that the 2009 approval of Multaq to reduce the risk of cardiovascular hospitalisation in patients with paroxysmal or persistent AF or atrial flutter was based on a different clinical study, where results showed that patients receiving the drug had a decreased number of deaths, versus placebo.

Meanwhile, the EMA's Committee for Medicinal Products for Human Use in January launched a review of Multaq following reports of severe liver injury. They said earlier this month that the review will now include data from the PALLAS trial. The agency plans to issue further guidance on the drug in September. Multaq is indicated for non-permanent AF in Europe.

Commenting on the news, Sanofi said "the benefit-risk profile remains positive" for the indications in which the drug is currently approved.

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