R.I.P. Dronedarone

Dronedarone (marketed as 'Multaq' by Sanofi-Adventis), amiodarone's weaker cousin, was initially hailed as a potentially safer drug substitute for long-term management of atrial fibrillation. Unfortunately, the drug died a quiet death at the hands of the FDA yesterday. The writing was on the walls, since earlier studies demonstrated only marginal efficacy compared to placebo. According the to Wall Street Journal today:

In a setback for Sanofi-Aventis, the Food and Drug Administration rejected the French drug maker's application to sell Multaq, a cardiovascular drug the company had hoped would become a blockbuster.

In a brief statement, Sanofi said the agency issued a "nonapprovable letter" for the drug's use against atrial fibrillation, a type of irregular heartbeat. Such a letter means the FDA found Sanofi's application didn't adequately demonstrate its safety or efficacy. Sanofi didn't say why Multaq was rejected but added it planned to resubmit the drug for approval in 2008, once it concludes a new clinical trial. A Sanofi spokesman declined to comment further on the FDA letter. An FDA spokeswoman also declined to comment.

Too bad. But the search for an Amiodarone substitute (to avoid its significant side effects) continues...

--Wes