Multaq approved for atrial fibrillation or atrial flutter
MULTAQ (Dronedarone) 400mg tablets from sanofi-aventis
The FDA has approved Multaq (dronedarone tablets, from Sanofi-aventis), an antiarrhythmic, to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors, who are in sinus rhythm or who will be cardioverted. This approval is based on five international, multicenter, randomized clinical trials, ATHENA, ANDROMEDA, EURIDIS, ADONIS, and DAFNE, involving nearly 6,300 patients. The ATHENA trial evaluated the safety and efficacy of Multaq in 4,628 patients with AF/AFL or a recent history of these conditions (71% had no heart failure, 29% were in NYHA class I–III with stable heart failure). This trial showed that Multaq, in addition to standard therapy, reduced the combined endpoint of cardiovascular hospitalization or death from any cause by 24% (p<0.001) when compared to placebo, meeting the study's primary endpoint.
Multaq will be available in the summer of 2009 in a 400mg dosage strength.