�Sanofi-aventis
(EURONEXT: SAN and NYSE: SNY) announced that U.S. Food and Drug
Administration (FDA) has assigned priority limited review status for its New Drug
Application (NDA) for Multaq(R) (dronedarone). The priority review time period
begins on July 31, 2008.
The priority review is given to applications in which a new
indication or new drug product, if approved, has the voltage to deliver a
safe and effective therapy where no satisfactory alternative exists
compared to currently useable therapies or marketed products.
A registration dossier is also under regulatory limited review by the European
Medicines Agency (EMEA) for a Marketing Authorization Application.
"We are pleased that the FDA has designated Multaq(R) for precedency
review," said 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 decreased the risk of
cardiovascular hospitalizations or death from any causal agent in patients with
Atrial Fibrillation."
Atrial fibrillation is a major cause of hospitalization and mortality
and affects about 2.5 million people in the United States, as well as 4.5
million people in the European Union and is rising as a growing public
health concern due to an ripening population. Patients suffering from atrial
fibrillation have double the risk of death, an increased risk of stroke and
cardiovascular complications, including congestive heart failure.
Furthermore atrial fibrillation considerably impairs patients' lives,
mainly because of their inability to execute normal daily activities due to
complaints of palpitations, chest botheration, dyspnoea, fatigue or
light-headedness.
About Multaq(R) (dronedarone)
Dronedarone (brand bring up Multaq(R)) is an investigational new discussion
for patients with atrial fibrillation, which has been discovered and
developed by sanofi-aventis for the bar and discourse 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 hold the i radical
and did not show any evidence of thyroid or pulmonary toxicity in clinical
trials.
About Sanofi Aventis
Sanofi-aventis, a ahead 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 outlined in
the Private Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements are statements that are not historical facts.
These statements include intersection 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
sane, investors ar cautioned that forward-looking information and
statements are issue to various risks and uncertainties, many of which
are hard to call and loosely beyond the control of
sanofi-aventis, that could causal agency actual results and developments to take issue
materially from those expressed in, or implied or projected by, the
forward-looking information and statements. These risks and uncertainties
include among former things, the uncertainties underlying in research and
development, future clinical data and analysis, including post selling,
decisions by regulatory government, such as the FDA or the EMEA, regarding
whether and when to approve whatsoever 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 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 therapeutical 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' yearly report on Form 20-F for the year over December 31,
2007. Other than as required by applicable law of nature, sanofi-aventis does not
undertake any obligation to update or revise any advanced
information or statements.
Sanofi Aventis
http://www.sanofi-aventis.com
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