Sanofi-Aventis to resubmit application for heart medication

BRIDGEWATER, N.J. Sanofi-Aventis plans to resubmit its application for its atrial fibrillation treatment Multaq following positive clinical data for the previously not-approvable drug.

In 2006, the Food and Drug Administration issued a not-approvable letter for Multaq, and the company said it would resubmit its application in the first part of 2008 after completion of a new trial. That trial, ATHENA, shows the drug decreased patients’ risk of cardiovascular hospitalizations or death from any cause by 24 percent, according to the company.

In the ATHENA trial, Multaq showed a 30 percent decrease in the risk of cardiovascular death on top of standard therapy, including rate control and anti-thrombotic drugs, in patients with atrial fibrillation or atrial flutter, the company said.

Multaq also significantly decreased the risk for death from arrhythmia by 45 percent, and there were fewer deaths from any cause in the Multaq group compared with placebo, according to the company. First cardiovascular hospitalization was reduced by 25 percent in the Multaq group.