- New treatment option to reduce cardiovascular hospitalization in patients with atrial fibrillation (AF) or atrial flutter (AFL) -
Paris, France – July 28, 2009 – Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that Multaq® (dronedarone) 400 mg Tablets is now available in pharmacies in the United States. Multaq® is an anti-arrhythmic drug indicated 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 (i.e., age >70, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter ≥50 mm or left ventricular ejection fraction [LVEF] <40%), who are in sinus rhythm or who will be cardioverted.
Multaq® was recently approved by the U.S. Food and Drug Administration on July 1, 2009.
“Multaq® may help patients with atrial fibrillation or atrial flutter stay out of the hospital, which is an important factor in treatment that is often not addressed,” said Gerald V. Naccarelli, M.D., Chief, Division of Cardiology, Pennsylvania State University College of Medicine. “We welcome a new option that may help patients with Afib or Aflutter manage their disease.”
In the landmark ATHENA trial, the efficacy and safety of Multaq® was evaluated in patients with AF/AFL or a recent history of these conditions (71% of these patients had no heart failure, 29% 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 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® 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.
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™), the Risk Evaluation and Mitigation Strategy (REMS). The mPACT Partnership was developed to assist healthcare professionals (HCPs) 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.
There are approximately 2.5 million Americans with AF and the incidence is growing worldwide in relation to the aging population. Atrial fibrillation is a complex disease that increases the risk of stroke up to five-fold, worsens the prognosis of patients with cardiovascular risk factors, and doubles the risk of mortality.
About Multaq® (dronedarone)
Multaq®, discovered and developed by sanofi-aventis, has been studied in a clinical development program involving nearly 6,300 patients including more than 3,200 patients who received Multaq®. It represents one of the few new treatment options for AF/AFL patients in the last 10 years. Multaq® is to be given twice daily as a 400 mg tablet and should be taken as one tablet with the morning and evening meals. Treatment with Multaq® can be initiated in an outpatient setting. Most common adverse reactions are diarrhea, nausea, vomiting, abdominal pain, asthenia (weakness) and cutaneous rash.
Important Safety Information
Multaq® is contraindicated in patients with NYHA Class IV heart failure or NYHA Class II-III heart failure with a recent decompensation requiring hospitalization or referral to a specialized heart failure clinic. In a placebo-controlled study in patients with severe heart failure requiring recent hospitalization or referral to a specialized heart failure clinic for worsening symptoms (the ANDROMEDA study), patients given dronedarone had a greater than two-fold increase in mortality. Such patients should not be given dronedarone.
Multaq® is also contraindicated in second- or third-degree atrioventricular (AV) block or sick sinus syndrome (except when used in conjunction with a functioning pacemaker), bradycardia <50 bpm, QTc Bazett interval ≥500 ms and severe hepatic impairment.
Multaq® should not be given to patients who are or may become pregnant (Category X) or nursing.
Multaq® should not be coadministered with strong CYP 3A inhibitors or medicinal products that prolong the QT interval.
In patients with new or worsening heart failure, the suspension or discontinuation of Multaq® should be considered.
Serum creatinine levels increase by about 0.1mg/dL following Multaq® treatment initiation. The elevation has a rapid onset, reaches a plateau after 7 days and is reversible after discontinuation.
Hypokalemia and hypomagnesemia may occur with concomitant administration of potassium-depleting diuretics. Potassium levels should be maintained in the normal range pre and during administration.
For full prescribing information, please visit: http://products.sanofi-aventis.us/Multaq/Multaq.pdf
About Atrial Fibrillation/Atrial Flutter
Atrial fibrillation is the most common arrhythmia, or irregular heartbeat, seen by physicians and accounts for about one-third of hospital admissions for cardiac rhythm disturbances. Hospitalization associated with AF has increased dramatically (two-to-three fold) in recent years in the U.S. Atrial flutter, another type of arrhythmia generating in the atrium, occurs less frequently, and may evolve into atrial fibrillation.
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Forward Looking Statements
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FOR MORE INFORMATION PLEASE VISIT: MULTAQ Web site: www.multaq.com