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

Paris (ots/PRNewswire)

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.
In the Summary of Positive Opinion, the CHMP has acknowledged
that dronedarone has been shown, in addition to its rhythm and rate
controlling properties, to decrease the risk of atrial
fibrillation-related hospitalisations.
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 combined endpoint of cardiovascular hospitalization or death from
any cause by 24% (p<0.001) when compared to placebo, meeting the
study's primary endpoint. Reported significant adverse events in the
Multaq(R) arm included diarrhea, nausea, bradycardia, QT-interval
prolongation and cutaneous rash.
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 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.
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 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.
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 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..

Contact:

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

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