2009-11-30

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


Paris, November 30 (ots/PRNewswire) -

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

Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today thatthe European Commission has granted marketing authorization forMultaq(R) (dronedarone - 400mg Tablets) in all 27 European memberstates. This approval follows the European Commission positiveopinion issued on September 25, 2009 by the Committee for MedicinalProducts for Human Use (CHMP) of the European Medicine agency (EMEA).

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

Multaq(R) discovered and developed by sanofi-aventis is the firstanti-arrhythmic drug approved in the European Union that has shown aclinical benefit to reduce cardiovascular hospitalizations or deathfrom any cause in patients with AF/AFL as described in the ATHENAtrial.

"The approval of Multaq(R) in the European Union is importantnews for atrial fibrillation patients who will now have access to anew treatment approach," said Marc Cluzel, MD, Executive VicePresident, Research and Development, sanofi-aventis. "The approval ofMultaq(R) is the result of more than 15 years of research anddevelopment conducted by sanofi-aventis and supported by thecommitment of the experts involved in the clinical developmentprogram and AF patients participating in the trials."

The use of dronedarone in unstable patients with NYHA class IIIand IV heart failure is contraindicated. Because of limitedexperience in stable patients with recent (1 to 3 months) NYHA classIII heart failure or with Left Ventricular Ejection Fraction (LVEF)<35%, the use of MULTAQ is not recommended in these patients.

The marketing authorisation of Multaq(R) was based on the reviewof a comprehensive clinical data package including seveninternational, multi-center, randomized clinical trials involvingmore than 7000 patients with almost 4000 patients receivingdronedarone during the clinical development program.

"This European approval is good news for doctors and patientssince atrial fibrillation affects about 4.5 million people in Europeand represents one-third of hospitalizations for arrhythmia in theEuropean Union" said Dr. Stefan H. Hohnloser J.W., GoetheUniversity's Division of Clinical Electrophysiology, Frankfurt,Germany, principal investigator of the ATHENA study. "Multaq(R) is asignificant step forward which could change the way we approach themanagement of atrial fibrillation and offers a new treatment optionto physicians in a field where there has been no significantanti-arrhythmic drug innovation for almost 20 years."

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

About dronedarone (Multaq(R))

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

The landmark ATHENA trial was the largest anti-arrhythmic drugtrial ever conducted in patients with AF/AFL, involving 4,628patients with a follow-up of 30 months. In this trial, dronedarone,on top of standard therapy, significantly reduced cardiovascularhospitalization or death by 24 percent when compared to placebo,meeting the study's primary endpoint. This reduction was generallyconsistent across study subgroups based on baseline characteristicsor medications.

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 daily400 mg tablets to be taken with morning and evening meals. Treatmentwith dronedarone does not require a loading dose and can be initiatedin an outpatient setting with minimal monitoring

The EURIDIS-ADONIS, ANDROMEDA and ATHENA trials were published inthe New England Journal of Medicine (NEJM) respectively in 2007, 2008and 2009.

About atrial fibrillation

The incidence of atrial fibrillation is growing worldwide inrelation to aging populations. It is emerging as a public healthconcern, affects about 4.5 million people in Europe and representsone-third of hospitalizations for arrhythmia in the EuropeanUnion(1). Atrial fibrillation leads to potential life-threateningcomplications. AF increases the risk of stroke up to five-fold(2),worsens the prognosis of patients with cardiovascular riskfactors(3), and doubles the risk of mortality(4) with significantburden on patients, health care providers and payers. Seventy percentof AF management costs are driven by hospital care and interventionalprocedure in the European Union(5).

About sanofi-aventis

Sanofi-aventis, a leading global pharmaceutical company,discovers, develops and distributes therapeutic solutions to improvethe lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT:SAN) and in New York (NYSE: SNY).

Forward Looking Statements

This press release contains forward-looking statements as definedin the Private Securities Litigation Reform Act of 1995, as amended.Forward-looking statements are statements that are not historicalfacts. These statements include product development, productpotential projections and estimates and their underlying assumptions,statements regarding plans, objectives, intentions and expectationswith respect to future events, operations, products and services, andstatements regarding future performance. Forward-looking statementsare generally identified by the words "expects," "anticipates,""believes," "intends," "estimates," "plans" and similar expressions.Although sanofi-aventis' management believes that the expectationsreflected in such forward-looking statements are reasonable,investors are cautioned that forward-looking information andstatements are subject to various risks and uncertainties, many ofwhich are difficult to predict and generally beyond the control ofsanofi-aventis, that could cause actual results and developments todiffer materially from those expressed in, or implied or projectedby, the forward-looking information and statements. These risks anduncertainties include among other things, the uncertainties inherentin research and development, future clinical data and analysis,including post marketing, decisions by regulatory authorities, suchas the FDA or the EMEA, regarding whether and when to approve anydrug, device or biological application that may be filed for any suchproduct candidates as well as their decisions regarding labelling andother matters that could affect the availability or commercialpotential of such products candidates, the absence of guarantee thatthe products candidates if approved will be commercially successful,the future approval and commercial success of therapeuticalternatives as well as those discussed or identified in the publicfilings with the SEC and the AMF made by sanofi-aventis, includingthose listed under "Risk Factors" and "Cautionary Statement RegardingForward-Looking Statements" in sanofi-aventis' annual report on Form20-F for the year ended December 31, 2008. Other than as required byapplicable law, sanofi-aventis does not undertake any obligation toupdate or revise any forward-looking information or statements.

References: 1 Go AS, Hylek EM, Phillips KA, et al. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA 2001; 285:2370-5. 2 Lloyd-Jones et al. Lifetime Risk for Development of Atrial Fibrillation: The Framingham Heart Study. Circulation. 2004; 110:1042-1046. 3 Fuster V et al. ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation. European Heart Journal (2006) 27, 1979-2030. 4 Benjamin EJ, Wolf PA, D'Agostino RB, Silbershatz H, Kannel WB, Levy D. Impact of atrial fibrillation on the risk of death: the Framingham Heart Study. Circulation 1998 Sep 8; 98(10):946-52.. 5 Ringborg et all, Europace 2008 10; 400-411 FOR MORE INFORMATION PLEASE VISIT: Dronedarone press office: http://www.dronedarone-atrial-fibrillation-pressoffice.com

ots Originaltext: sanofi-aventis GroupIm Internet recherchierbar: http://www.presseportal.de

Contact:MEDIA CONTACT: Philippe BARQUET, Tel: +33(0)6-70-48-61-28, Email: philippe.barquet@sanofi-aventis.com

sanofi-aventis Group

Zurück zur Übersiche Medizin-Nachrichten

Preisvergleich Medikamente
Medikament oder PZN:   
In Zusammenarbeit mit Medizinfuchs

News

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

Medizin-News