Sanofi-Aventis has made Multaq (dronedarone) 400 mg tablets available in pharmacies in the U.S. Multaq, an anti-arrhythmic drug, is indicated to reduce the risk of cardiovascular (CV) hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated CV risk factors, who are in sinus rhythm or who will be cardioverted.
Multaq was FDA approved on July 1.
In the ATHENA trial, the efficacy and safety of Multaq was evaluated in patients with AF/AFL or a recent history of these conditions (71 percent of these patients had no heart failure, 29 percent had NYHA class I-III stable heart failure). This trial showed that Multaq 400 mg BID, in addition to standard therapy, reduced the combined endpoint of CV hospitalization or death from any cause by 24 percent when compared to placebo, meeting the study's primary endpoint. The Paris-based company noted that patients taking Multaq had higher rates of diarrhea, nausea, bradycardia, QT-interval prolongation and cutaneous rash than patients taking placebo.
According to the FDA approval, initiation of Multaq is contraindicated in patients with severe heart failure (NYHA class IV) or NYHA Class II - III heart failure with a recent decompensation requiring hospitalization or referral to a specialized heart failure clinic. This unstable population corresponds to the population of the ANDROMEDA trial in which patients receiving dronedarone had a greater than two-fold increase in mortality compared to placebo.
To ensure the use of Multaq in the appropriate patient population, sanofi-aventis U.S. also launched mPACT Multaq Partnership for Appropriate Care and Treatment, the Risk Evaluation and Mitigation Strategy. The mPACT Partnership was developed to assist healthcare professionals with the identification of appropriate patients and to ensure the safe use of Multaq.