Replacement for Amiodarone Fast-Tracked by the FDA
August 11, 2008 6:12 AM CT
There is good news for those on amiodarone, or those trying to avoid it.
Amiodarone is among the most effective atrial fibrillation medications, but amiodarone has major toxicity issues.
Multaq® (dronedarone) is a new drug for atrial fibrillation and atrial flutter that is a potential replacement for amiodarone. Multaq® just received priority review status from the US FDA. This fast-track status is granted to new drug applications that have the potential to be safe and effective, if approved, and where no satisfactory therapies now exist.
Multaq® has the benefits of amiodarone, but without the iodine radicals responsible for amiodarone’s toxicity. In clinical trials, dronedarone did not show thyroid or pulmonary toxicity. It is a multi-channel blocker that affects calcium, potassium, and sodium channels and has anti-adrenergic properties.
The recent results from the ATHENA study showed that Multaq® significantly decreased the risk of cardiovascular hospitalizations or death from any cause in patients with Atrial Fibrillation by 24%.
UPDATED 11-27-2008: The FDA review of Multaq that was expected in December or January has now been pushed out to March 18, 2009.
DISCLAIMER ADDED 12-30-2008: The maker of Multaq® (dronedarone) has just come on board as a sponsor at StopAfib.org. We have decided to leave this article posted as it was written several months earlier and was an unbiased perspective at the time. We feel that taking it down would be a disservice to those on amiodarone who are seeking solutions.