MEDIA RELEASE PR37327
Sanofi-aventis: Multaq(R) Approved in the European Union for Patients With Atrial Fibrillation
PARIS, Nov. 30/PRNewswire-AsiaNet/ --
- First New Anti-Arrhythmic Drug to be Approved in the European
Union in the Last 10 Years
Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today
that the European Commission has granted marketing authorization for
Multaq(R) (dronedarone - 400mg Tablets) in all 27 European member states.
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
cause in patients with AF/AFL as described in the ATHENA trial.
"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
and Development, sanofi-aventis. "The approval of Multaq(R) is the result of
more than 15 years of research and development conducted by sanofi-aventis
and supported by the commitment of the experts involved in the clinical
development program and AF patients participating in the trials."
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
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
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
Union" said Dr. Stefan H. Hohnloser J.W., Goethe University's Division of
Clinical Electrophysiology, Frankfurt, Germany, principal investigator of the
ATHENA study. "Multaq(R) is a significant step forward which could change the
way we approach the management of atrial fibrillation and offers a new
treatment option to physicians in a field where there has been no significant
anti-arrhythmic drug innovation for almost 20 years."
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
therapy, significantly reduced cardiovascular hospitalization or death by 24
percent when compared to placebo, meeting the study's primary endpoint. This
reduction was generally consistent across study subgroups based on baseline
characteristics or 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 daily 400 mg
tablets to be taken with morning and evening meals. Treatment with
dronedarone does not require a loading dose and can be initiated in an
outpatient setting with minimal monitoring
The EURIDIS-ADONIS, ANDROMEDA and ATHENA trials were published
in the New England Journal of Medicine (NEJM) respectively in 2007, 2008 and
2009.
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
New York (NYSE: SNY).
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
expectations reflected in such forward-looking statements are reasonable,
investors are cautioned that forward-looking information and statements are
subject to various risks and uncertainties, many of which are difficult to
predict and generally beyond the control of sanofi-aventis, that could cause
actual results and developments to differ materially from those expressed in,
or implied or projected by, the forward-looking information and statements.
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,
the absence of guarantee that the products candidates if approved will be
commercially successful, the future approval and commercial success of
therapeutic alternatives as well as those discussed or identified in the
public filings with the SEC and the AMF made by sanofi-aventis, including
those listed under "Risk Factors" and "Cautionary Statement Regarding
Forward-Looking Statements" in sanofi-aventis' annual report on Form 20-F for
the year ended December 31, 2008. Other than as required by applicable law,
sanofi-aventis does not undertake any obligation to update 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
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SOURCE: Sanofi-aventis
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