Sanofi-Aventis has announced that Multaq (dronedarone) is now available in the US for patients with atrial fibrillation (AF) or atrial flutter (AFL).
Multaq is an anti-arrhythmic drug indicated to reduce the risk of cardiovascular hospitalisation in patients with paroxysmal or persistent AF or AFL.
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The announcement follows approval granted by the US Food and Drug Administration (FDA) on 1 July 2009.
Pennsylvania State University College of Medicine Division of Cardiology chief Gerald V Naccarelli said that the drug is a welcome new option.
“Multaq may help patients with AF or AFL stay out of the hospital, an important factor in treatment that is often not addressed,” Naccarelli said.
Approval was granted based on the landmark ATHENA trial, in which the efficacy and safety of Multaq was evaluated in patients with AF/AFL or a recent history of these conditions.
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By GlobalDataThe trial showed that Multaq 400mg BID, in addition to standard therapy, reduced the combined endpoint of cardiovascular hospitalisation or death from any cause by 24% when compared to placebo.
