July 6, 2009 – Sanofi-aventis said last week the FDA approved its Multaq (dronedarone) 400 mg tablets for use in patients with atrial fibrillation (AF) or atrial flutter (AFL).
Multaq is the first drug approved in the United States that has shown a clinical benefit to reduce cardiovascular hospitalization in patients with AF/AFL, the company said. Multaq is an antiarrhythmic indicated to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent AF or AFL, with a recent episode of AF/AFL and associated cardiovascular risk factors, who are in sinus rhythm or who will be cardioverted. Associated cardiovascular risk factors include age over 70 years, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter greater than or equal to 50 mm or left ventricular ejection fraction of less than 40 percent.
The FDA approval is based on five international, multicenter, randomized clinical trials involving nearly 6,300 patients. The landmark ATHENA trial evaluated the efficacy and safety of Multaq in patients with AF/AFL or a recent history of these conditions (71 percent of these patients had no heart failure, 29 percent were in NYHA class I-III with stable heart failure). This trial showed that Multaq 400 mg, in addition to standard therapy, reduced the combined endpoint of cardiovascular hospitalization or death from any cause by 24 percent when compared to placebo, the company said. This reduction was generally consistent across study subgroups based on baseline characteristics or medications. Patients taking Multaq had higher rates of diarrhea, nausea, bradycardia, QT-interval prolongation and cutaneous rash than patients taking placebo.
Initiation of Multaq treatment 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. The ATHENA and ANDROMEDA trials provided two sets of data supporting the assessment of the product’s benefit risk ratio in two significantly different patient populations.
To ensure the use of Multaq in the appropriate patient population, sanofi-aventis U.S. LLC also announced the launch of mPACT (Multaq Partnership for Appropriate Care and Treatment) to evaluate risks. Partnership was developed to assist healthcare professionals with the identification of appropriate patients and to ensure the safe use of Multaq, while minimizing risk. The risk mitigation program consists of a Communication Plan for HCPs, a medication guide for patients and post-marketing surveillance.
For more information: www.sanofi-aventis.com