BN004390 30 de novembro de 2009 08:23 HORALOCAL
- First New Anti-Arrhythmic Drug to be Approved in the European Union
in the Last 10 Years
PARIS, Nov. 30 /PRNewswire/ -- 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
FOR MORE INFORMATION PLEASE VISIT:
Dronedarone press office:
http://www.dronedarone-atrial-fibrillation-pressoffice.com
CONTACT: Philippe Barquet of sanofi-aventis, +33(0)6-70-48-61-28,
philippe.barquet@sanofi-aventis.com
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