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Sanofi-aventis is Complying With the EMEA's Recommendation to Temporarily Suspend the Marketing Authorisation of Acomplia(R) in Obese and Overweight Patients

Paris (ots/PRNewswire)

  • Sanofi-aventis Will Comply With the European Authorities Request to Temporarily Suspend the Marketing Authorisation of Acomplia(R) in Obese and Overweight Patients and Will Make Every Effort to Actively Support Patients and Health Care Professionals in This Process.
  • Sanofi-aventis is Committed to Provide Additional Evidence for the Re-evaluation of the Benefit / Risk Profile of Acomplia(R) in patients with diabetes and Cardiovascular Diseases Through the ongoing Clinical studies.
  • Sanofi-aventis Remains Committed to Acomplia(R) to Bring an Important Therapeutic Approach to Obese and Overweight Patients.
Sanofi-aventis announced today that the European Medicines Agency
(EMEA) has recommended to the European Commission (EC) the temporary
suspension of the marketing authorisation of Acomplia(R) (rimonabant)
for the approved indication of overweight and obese patients.
Acomplia(R) has been marketed in 18 EU countries since 2006 and
has provided significant clinical benefits to patients suffering from
obesity and overweight with associated co-morbidities.
Since the start of the commercialisation of Acomplia(R),
sanofi-aventis has been closely collaborating with both the
regulatory authorities and healthcare providers to monitor on an
ongoing basis the real life use of the product and to ensure its use
in the right patient population.
More than 700,000 patients have been treated with Acomplia(R)
world-wide to date. In the postmarketing surveillance of Acomplia the
safety profile of the product is aligned to the one described in the
current European SmPC for the product and is consistent with the one
observed during the clinical development.
"This first in its class medication continues to demonstrate
great promise to reduce cardiometabolic risk and the pattern of side
effects remains consistent across the randomized clinical trials
conducted to date. As with any new drug category, more will be
learned about optimizing benefit and minimizing risk through
continuing controlled use of the medication in different patient
populations. While the pendulum has swung in the direction of extreme
caution with today's regulatory decision, at the end of the day, the
medical community will allow the scientific process to unfold before
rendering any final decisions about this medication's ultimate
therapeutic potential" declared Robert Anthenelli, M.D. Professor of
Psychiatry, Psychology and Neuroscience University of Cincinnati
College of Medicine and Cincinnati Veterans Affairs Medical Center.
Sanofi-aventis believes that Acomplia(R) will remain an important
therapeutic answer to a highly prevalent and increasing unmet medical
need. As discussed with the EMEA, sanofi-aventis will continue the
ongoing clinical trial program except phase IV and is committed to
provide additional evidence for the positive re-evaluation of the
benefit / risk profile of Acomplia(R), including through studies in
diabetes and in patients at risk of cardiovascular disease.
Inline with its commitment to the EMEA, sanofi-aventis and its
subsidiaries will inform Health Care Professionals as of today of the
temporary marketing authorisation suspension. Patients who are
currently taking Acomplia(R) should consult their doctor or
pharmacist at a convenient time to discuss their treatment.
Sanofi-aventis will enter immediately in discussion with health
care authorities in non European Union countries where Acomplia is
available to determine how to implement an equivalent EMEA decision.
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). For more information, please visit:
http://www.sanofi-aventis.com.
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, 2007. Other than as required by
applicable law, sanofi-aventis does not undertake any obligation to
update or revise any forward-looking information or statements.
Contact for Medical Inquiries:
Please refer to the local sanofi-aventis office.

Contact:

Contact for Media inquiries: Salah Mahyaoui - Global Product
Communication - Tel : +33-6-73-68-78-88. Ingrid Goerg-Armbrecht -
Global Product Communication, Metabolism Tél :+33-6-86-05-66-88.
Jean-Marc Podvin - Media Relations - Tel : +33-6-74-57-51-70.
Geoffroy Bessaud - Media Relations - Tel : +33-6-71-62-85-54

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