Sanofi-Aventis Waits for FDA’s Decision on Multaq (Dronedarone) Heart Drug

By Alice Carver
14:38, February 12th 2009
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Sanofi-Aventis Waits for FDA’s Decision on Multaq (Dronedarone) Heart Drug

The FDA is expected to take a decision regarding an experimental drug from Sanofi-Aventis which is aimed at treating irregular heart rythms, a condition that could pose serious threat to our health.

A panel of cardiology expert will meet March 18 to assess the drug dronedarone. Dronedarone is tested for atrial fibrillation, a condition that affects an estimated 2.2 million Americans. The condition may lead to circulation problems and dangerous blood clots.

Current treatments include blood thinning drugs or open heart surgery for the most severe cases.

Statistics show that the number of hospitalizations due to atrial fibrillation has increased dramatically in recent years in the United States.

Results from the ATHENA trial published in the New England Journal of Medicine showed a significant decrease in the risk of cardiovascular death by 24 percent in patients treated with the drug. The trial included 2,301 people with atrial fibrillation. About 30 percent of those who started the trial had to stop the drug.

Experts caution that the drug is not safe for those with advanced heart failure.

“The ATHENA trial is the first trial to show a reduction in the incidence of cardiovascular hospitalization or death in patients taking an anti-arrhythmic drug for atrial fibrillation” commented Dr. Stefan H. Hohnloser J.W., Goethe University's Division of Clinical Electrophysiology, Frankfurt, Germany, lead investigator of the ATHENA study was quoted as saying.

According to the medical company, the FDA announced it would give the drug a priority review. The trial of dronedarone (Multaq) was sponsored by the drug’s maker, Sanofi-Aventis.



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