Sanofi Aventis : Multaq(R) (dronedarone) Recommended for Approval in the European Union

Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has adopted a positive opinion recommending to grant a marketing authorization in the European Union for Multaq(R) (dronedarone - 400mg Tablets).

The CHMP has recommended the approval of Multaq(R) in adult clinically stable patients with history of, or current non-permanent atrial fibrillation (AF) to prevent recurrence of AF or to lower ventricular rate.

The positive opinion from the CHMP needs now to be ratified by the European Commission.

"Sanofi-aventis welcomes the positive CHMP recommendation for the approval of Multaq(R) in the European Union" said Jean-Pierre Lehner, Chief Medical Officer, sanofi-aventis. "This decision brings new hope to people whose lives are impacted by the potential cardiovascular complications of atrial fibrillation. We do think that Multaq(R) will contribute to fulfill significant unmet medical needs for the patients".

The CHMP positive opinion is based on the submission of a comprehensive clinical data package including seven international, multi-center, randomized clinical trials involving more than 7000 patients and including the landmark ATHENA trial.

The ATHENA trial involved 4,628 patients with Atrial Fibrillation / Atrial Futter or a recent history of these conditions and showed that Multaq(R) (dronedarone) in addition to standard therapy, reduced

The incidence of atrial fibrillation is growing worldwide in relation to aging populations. It is emerging as a public health concern and affects about 4.5 million people and represents one-third of hospitalizations

Multaq(R) has recently received approval from the U.S. Food and Drug Administration (FDA), Health Canada and Swissmedic (Swiss Health Authority).

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 statements include product development, product potential projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans" and similar expressions. Although sanofi-aventis' management believes that the

FOR MORE INFORMATION PLEASE VISIT:

Dronedarone press office:

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

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.

SOURCE: Sanofi Aventis Groupe

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

• ข่าวthe European Union
• ข่าวdronedarone
• ข่าวo:heal
• ข่าวo:asn
• ข่าวo:gen