Sanofi-aventis: Multaq(R) Approved in the European Union for Patients With Atrial Fibrillation

- First New Anti-Arrhythmic Drug to be Approved in the European Union in the Last 10 Years

This approval follows the European Commission positive opinion issued on September 25, 2009 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicine agency (EMEA).

Multaq(R) is indicated in adult clinically stable patients with a history of, or current non-permanent atrial fibrillation (AF) to prevent recurrence of AF or to lower ventricular rate.

Multaq(R) discovered and developed by sanofi-aventis is the first anti-arrhythmic drug approved in the European Union that has shown a clinical benefit to reduce cardiovascular hospitalizations or death from any

"The approval of Multaq(R) in the European Union is important news for atrial fibrillation patients who will now have access to a new treatment approach," said Marc Cluzel, MD, Executive Vice President, Research

The use of dronedarone in unstable patients with NYHA class III and IV heart failure is contraindicated. Because of limited experience in stable patients with recent (1 to 3 months) NYHA class III heart failure or

The marketing authorisation of Multaq(R) was based on the review of a comprehensive clinical data package including seven international, multi-center, randomized clinical trials involving more than 7000 patients with almost 4000 patients receiving dronedarone during the clinical development program.

"This European approval is good news for doctors and patients since atrial fibrillation affects about 4.5 million people in Europe and represents one-third of hospitalizations for arrhythmia in the European

The first launches of Multaq(R) are expected to take place in the United Kingdom and Germany in January 2010. Multaq(R) is already approved in the United States, Canada, Switzerland and Brazil.

About dronedarone (Multaq(R))

The marketing authorisation of Multaq(R) was based on the review of four placebo controlled studies in patients with atrial fibrillation (AF) or atrial flutter (AFL) called EURIDIS, ADONIS, ERATO and ATHENA; the DIONYSOS trial, a comparative trial vs amiodarone; and the ANDROMEDA trial, a placebo controlled study in heart failure patients with a recent hospitalization for decompensated systolic heart failure.

The landmark ATHENA trial was the largest anti-arrhythmic drug trial ever conducted in patients with AF/AFL, involving 4,628 patients with a follow-up of 30 months. In this trial, dronedarone, on top of standard

The most common adverse reactions were diarrhea, nausea, vomiting, abdominal pain, asthenia (weakness) and skin rash. Dronedarone has a convenient fixed dose regimen of twice daily 400 mg

About atrial fibrillation

The incidence of atrial fibrillation is growing worldwide in relation to aging populations. It is emerging as a public health concern, affects about 4.5 million people in Europe and represents one-third of hospitalizations for arrhythmia in the European Union(1). Atrial fibrillation leads to potential life-threatening complications. AF increases the risk of stroke up to five-fold(2), worsens the prognosis of patients with cardiovascular risk factors(3), and doubles the risk of mortality(4) with significant burden on patients, health care providers and payers. Seventy percent of AF management costs are driven by hospital care and interventional procedure in the European Union(5).

About sanofi-aventis

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

Forward Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts.

These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMEA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such products candidates,

References:

1 Go AS, Hylek EM, Phillips KA, et al. Prevalence of diagnosed atrial

2 Lloyd-Jones et al. Lifetime Risk for Development of Atrial

3 Fuster V et al. ACC/AHA/ESC 2006 guidelines for the management of

4 Benjamin EJ, Wolf PA, D'Agostino RB, Silbershatz H, Kannel WB, Levy D.

FOR MORE INFORMATION PLEASE VISIT:

Dronedarone press office:

http://www.dronedarone-atrial-fibrillation-pressoffice.com

SOURCE: Sanofi-aventis

--Distributed by AsiaNet ( www.asianetnews.net )--

• ข่าวAtrial Fibrillation
• ข่าวthe European Union
• ข่าวdronedarone
• ข่าวo:heal
• ข่าวo:asn