FDA Approves Dronedarone for Atrial Fibrillation

July 03, 2009

July 3, 2009 (Silver Spring, Maryland) — The US Food and Drug Administration (FDA) has approved dronedarone (Multaq, Sanofi-Aventis) to reduce the risk of cardiovascular hospitalization in the treatment of atrial fibrillation (AF) or atrial flutter.

The decision follows the recommendation of the Cardiovascular and Renal Drug Advisory Panel, which earlier this year voted 10-3 in favor of approval, a decision reported by heartwire . Dronedarone is envisioned as a safer alternative to amiodarone, a widely used antiarrhythmic agent in patients with AF.

The advisory panel recommendation and the FDA approval are based largely on the results of the ATHENA study. In that trial, treatment with dronedarone resulted in a 24% reduction in the risk of all-cause mortality or cardiovascular hospitalization when compared with placebo. The study, led by Dr Stefan H Hohnloser (JW Goethe University, Frankfurt, Germany), was published in the February 12, 2009 issue of the New England Journal of Medicine [1].

The FDA approval is good news for Sanofi-Aventis, which tried unsuccessfully to have dronedarone approved for use in patients with systolic heart failure. The current approval states that dronedarone is contraindicated in patients with severe heart failure or those with NYHA 2 or 3 heart failure with a recent decompensation requiring hospitalization. The ANDROMEDA trial, also reported by heartwire , showed that dronedarone increased the risk of mortality twofold among those treated with the drug.