The French drug company Sanofi-Aventis has asked the US Food and Drug Administration (FDA) to reconsider its heart rhythm drug Multaq (dronedarone), which the agency rejected in 2006.
The company said it would resubmit its application in the third quarter of this year, based on a new study showing that the drug reduced deaths and hospital admissions in patients with atrial fibrillation, in which the upper chambers of the heart quiver instead of beating properly. Atrial fibrillation affects about 2.2 million Americans and 4.5 million people in the European Union, and these patients have a higher risk of stroke and other cardiovascular complications, including heart failure.
Sanofi-Aventis presented the clinical trial, called ATHENA, at a meeting of the Heart Rhythm Society in San Francisco. According to the company, Multaq lowered the risk of cardiovascular death by 30% when added to standard treatment, and cut first hospital admissions for cardiovascular causes by 25%.
Update: the FDA approved Multaq in 2009 for some patients with atrial fibrillation, but later studies showed it is unsafe in patients with severe heart failure or permanent atrial fibrillation.
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