FDA advisory panel recommends approval of dronedarone

Henry I. Bussey, Pharm.D., FCCP, FAHA
March, 2009

FDA advisory panel recommends approval of dronedarone (an amiodarone-like antiarrhythmic) with a split vote (10 to 3) and "cautious yes" votes. The FDA does not have to follow the panel's recommendation, but it usually does. The primary concern about this drug is based on an increased death rate in an earlier trial of patients with severe heart failure. A more recent study that excluded patients with severe heart failure did not find an increased mortality rate but did report a 24% reduction in the primary endpoint of death from any cause or cardiovascular hospitalization (the difference was due to a reduction in cardiovascular hospitalizations, not mortality). Some authorities also indicated a desire for more long-term data.

More information is available at the links below:

FDA advisory panel recommends dronedarone approval for atrial fib - article on theheart.org

Dronedarone (an investigational anti-arrhythmic) reduces hospitalizations and cardiovascular death but not total mortality in selected patients with atrial fibrillation (the ATHENA trial) - ClotCare article