FDA Approves Multaq(R) for Patients with Atrial Fibrillation or Atri...(of these conditions (71% of these patien...),Health

Date:7/2/2009

of these conditions (71% of these patients had no heart failure, 29% were in NYHA class I-III with stable heart failure). This trial showed that Multaq(R) (dronedarone) 400 mg BID, 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. This reduction was generally consistent across study subgroups based on baseline characteristics or medications. Patients taking Multaq(R) had higher rates of diarrhea, nausea, bradycardia, QT-interval prolongation and cutaneous rash than patients taking placebo.

Initiation of Multaq(R) 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 2-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(R) in the appropriate patient population, sanofi-aventis U.S. LLC also announced the launch of mPACT(TM) - Multaq(R) Partnership for Appropriate Care and Treatment - the Risk Evaluation and Mitigation Strategy (REMS) developed by sanofi-aventis U.S. LLC. The mPACT(TM) Partnership was developed to assist healthcare professionals (HCPs) with the identification of appropriate patients and to ensure the safe use of Multaq(R) while minimizing risk. The risk mitigation program consists of a Communication Plan for HCPs, a medication guide for patients and post-marketing surveillance.

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