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news.Sanofi-Aventis has announced that findings from the landmark Athena study showed that Multaq, a potential therapy for the treatment of atrial fibrillation or atrial flutter, decreased the risk of cardiovascular hospitalizations or death from any cause by a statistically significant 24%, meeting the study's primary endpoint.
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The drug has showed a significant decrease in the risk of cardiovascular death by 30% (p=0.03) on top of standard therapy, including rate control and antithrombotic drugs, in patients with atrial fibrillation or atrial flutter. The drug also significantly decreased the risk of arrhythmic death by 45% (p=0.01) and there were numerically fewer deaths (16%) from any cause in the dronedarone group compared to placebo (p=0.17). First cardiovascular hospitalization was reduced by 25% (p=0.000000009) in the dronedarone group.
Based upon this new clinical data, the company plans to submit a registration dossier to the European Medicines Agency (EMEA), and a new drug application to the FDA during the third quarter of 2008.
Marc Cluzel, senior vice president, R&D, Sanofi-Aventis, said: “The Athena results have the potential to change the face of atrial fibrillation management. For atrial fibrillation patients, who together with their physicians struggle on a daily basis to manage the dramatic consequences of this complex disease, Multaq carries hope for patients.”