�Sanofi-aventis
(EURONEXT: SAN and NYSE: SNY) announced that U.S. Food and Drug
Administration (FDA) has assigned priority recap status for its New Drug
Application (NDA) for Multaq(R) (dronedarone). The precedence review period
begins on July 31, 2008.
The priority review is given to applications in which a modern
indication or new drug product, if approved, has the potential drop to present a
safe and effective therapy where no satisfactory alternative exists
compared to currently available therapies or marketed products.
A enrollment dossier is also under regulatory review by the European
Medicines Agency (EMEA) for a Marketing Authorization Application.
"We are proud of that the FDA has designated Multaq(R) for precedency
review," aforesaid Marc Cluzel, sanofi-aventis Senior Vice President, R&D for
sanofi-aventis. "This follows the exciting results of the landmark ATHENA
study that showed Multaq(R) significantly reduced the risk of
cardiovascular hospitalizations or death from any grounds in patients with
Atrial Fibrillation."
Atrial fibrillation is a major cause of hospitalization and mortality
and affects virtually 2.5 million people in the United States, as well as 4.5
trillion people in the European Union and is emerging as a growing populace
health concern due to an ripening population. Patients suffering from atrial
fibrillation have twice the risk of death, an increased risk of stroke and
cardiovascular complications, including congestive heart bankruptcy.
Furthermore atrial fibrillation well impairs patients' lives,
primarily because of their inability to perform normal daily activities due to
complaints of palpitations, chest pain, dyspnoea, fatigue or
light-headedness.
About Multaq(R) (dronedarone)
Dronedarone (brand diagnose Multaq(R)) is an investigational new handling
for patients with atrial fibrillation, which has been discovered and
developed by sanofi-aventis for the bar and handling of patients
with atrial fibrillation or atrial flutter. Dronedarone is a multi-channel
blocker that affects calcium, potassium and sodium channels and has
anti-adrenergic properties. Dronedarone does not contain the iodine radical
and did non show any evidence of thyroid or pulmonary toxicity in clinical
trials.
About Sanofi Aventis
Sanofi-aventis, a preeminent 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 weigh release contains forward-looking statements as defined in
the Private Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements ar statements that are non historical facts.
These statements include product development, mathematical 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 ar cautioned that forward-looking selective information and
statements are subject to versatile risks and uncertainties, many of which
are difficult to promise and generally beyond the control of
sanofi-aventis, that could suit actual results and developments to disagree
materially from those explicit 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 selling,
decisions by regulatory regime, 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 labeling and other matters that could affect the availability or
commercial voltage of such products candidates, the absence of vouch
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,
2007. Other than as required by applicable constabulary, sanofi-aventis does not
undertake any duty to update or revise any advanced
information or statements.
Sanofi Aventis
http://www.sanofi-aventis.com
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