FDA Approves Multaq(R) for Patients with Atrial Fibrillation or Atri...( PARIS July 2 /- Sanofi-aventis (EUR...),Health

PARIS, July 2 /PRNewswire-FirstCall/ -- Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that the U.S. Food and Drug Administration (FDA) has approved Multaq(R) (dronedarone) 400 mg Tablets. Patients with atrial fibrillation (AF) or atrial flutter (AFL) soon will have a new treatment option to help improve current management of their disease. Multaq(R) is the first drug approved in the United States that has shown a clinical benefit to reduce cardiovascular hospitalization in patients with AF/AFL.

Multaq(R) is an anti-arrhythmic 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, 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 [LVEF] <40%. The FDA approval is based on five international, multi-center, randomized clinical trials involving nearly 6,300 patients.

"The FDA approval of Multaq(R) is an important milestone in the management of atrial fibrillation or atrial flutter that demonstrates the commitment of sanofi-aventis to provide patients and physicians with important new medicines in therapeutic areas with significant healthcare needs," said Christopher A. Viehbacher, Chief Executive Officer of sanofi-aventis. "Sanofi-aventis is proud of its ability to bring innovative therapies to market and contribute to reducing the public health burden of atrial fibrillation."

The landmark ATHENA trial evaluated the efficacy and safety of Multaq(R) in patients with AF/AFL or a recent history
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