A panel of cardiology experts recommended Wednesday that Sanofi-Aventis experimental drug Multaq be approved to treat atrial fibrillation, a condition that could pose serious threat to our health.

 

The Food and Drug Administration’s panel voted 10-3 in favor of the drug generically known as dronedarone, which is designed to act through multiple channels to help restore and maintain normal heart rhythms in patients with atrial fibrillation and atrial flutter.

 

Atrial fibrillation can lead to palpitations, fainting, fatigue or congestive heart failure. It can also lead to blood clots and stroke. The condition becomes more common with age and can be treated with medication. About 1 in 100 people, and nearly 9 in 100 over the age of 80, have atrial fibrillation.

 

Some 70,000 Americans a year have embolic strokes, which can be caused by atrial fibrillation where the blood "pools" and sometimes clots in the atria (chambers of the heart), from which a piece breaks off and causes the stroke.

 

Multaq was rejected by the FDA in 2006 mostly because of a study, known as Andromeda, in patients with severe heart failure. That study was stopped early because patients taking Multaq had higher death rates and cardiovascular problems compared with those not taking the drug.

 

Sanofi was required to conduct an additional study, known as Athena, which showed that 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.

 

“The panel's insightful feedback which concluded with a positive vote is an important step in gaining FDA approval,” said Sanofi's Chief Medical Officer Jean-Pierre Lehner, in a statement.

 

The FDA does not necessarily have to side with their advisory panels, but in most cases they do.