Sanofi's Multaq gets FDA priority review

The US Food and Drug Administration has assigned priority review status for French drug major Sanofi-Aventis' New Drug Application for Multaq (dronedarone), which began on July 31, the firm has revealed. The drug was previously rejected by the FDA after it was filed in 2006, but has been resubmitted with new clinical data showing that it reduced the risk of death in patients with atrial fibrillation.

The priority review is granted to applications in which a new indication or new drug product, if approved, has the potential to present a safe and effective therapy where no satisfactory alternative exists compared to currently-available therapies or marketed products.

A registration dossier is also under regulatory review by the European Medicines Agency (EMEA) for a Marketing Authorization Application and, if Multaq gains regulatory approval, observers believe it will have blockbuster sales potential.