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Sanofi-aventis: Multaq(R) Receives Positive Recommendation by NICE in New Appraisal Consultation Document

Paris, March 30, 2010 (ots/PRNewswire)

Sanofi-aventis  announced today
that the National Institute for Health and Clinical Excellence (NICE)
in England and Wales, has just published a new appraisal consultation
document (ACD)[1] for Multaq(R) (dronedarone) indicating its
intention to recommend Multaq(R) use for the management of patients
with atrial fibrillation (AF).
The NICE appraisal committee's preliminary recommendation is to
endorse Multaq(R) as a first choice therapeutic option after
beta-blockers, which are the initial therapeutic option in the NICE
clinical guidelines. Based on this recommendation, Multaq(R) should
be prescribed in non-permanent AF patients with at least one of the
following cardiovascular risk factors: hypertension requiring drugs
of at least two different classes, diabetes mellitus, previous
transient ischemic attack, stroke or systemic embolism, left atrial
diameter of 50mm of greater, LVEF less than 40% or age 70 years or
older and who do not have unstable New York Heart Association (NYHA)
class III or IV heart failure.
This patient population corresponds to the patients included in
the landmark ATHENA study, the largest study ever performed with an
anti-arrhythmic drug in atrial fibrillation and the only study to
have ever demonstrated a positive impact on cardiovascular (CV)
morbidity and mortality.
In ATHENA, Multaq(R) reduced the risk of cardiovascular
hospitalization or death by a significant 24% vs. placebo on top of
standard of care including beta-blockers (p<0.001) with no difference
in the rate of serious adverse events (19.9% vs 21.1% respectively; p
= 0.31).
"Sanofi-aventis is pleased that NICE has acknowledged the
benefits of Multaq(R) for non-permanent AF patients who have been
awaiting a new therapeutic option that safely treats their symptoms
and improves their long-term cardiovascular outcomes," declared Belen
Garijo, Senior Vice President, Pharmaceutical Operations Europe,
sanofi-aventis. "We appreciate the thorough and comprehensive
evaluation of the Multaq(R) clinical and economic dossier that NICE
has performed and believe that this preliminary recommendation by
NICE provides a valuable benchmark to guide sanofi-aventis' ongoing
efforts to have the Multaq(R) value proposition in AF patients
recognized within Europe and beyond."
Multaq(R) will be commercially available in the UK from today,
Tuesday, March 30, 2010.
About Multaq(R)
Multaq(R), discovered and developed by sanofi-aventis, has been
studied in a clinical development program, including seven
international, multi-center, randomized clinical trials involving
more than 7000 patients with almost 4000 patients receiving
Multaq(R). The landmark ATHENA trial was the largest anti-arrhythmic
drug trial conducted in patients with AF/AFL, involving 4,628
patients with a follow-up of 30 months. In this trial, Multaq(R), on
top of standard cardiovascular therapy, significantly reduced
cardiovascular hospitalization or death by 24 percent (p<0.001) when
compared to placebo, meeting the study's primary endpoint. This
result was entirely attributable to a reduction in cardiovascular
hospitalization.
Multaq(R) has a fixed dose regimen of twice daily 400 mg tablets
to be taken with morning and evening meals. Treatment with Multaq(R)
does not require a loading dose and can be initiated in an outpatient
setting. Most common adverse reactions are diarrhea, nausea,
vomiting, abdominal pain, asthenia (weakness) and skin rash.
The European Commission granted marketing authorization for
Multaq(R) in November 2009. Multaq(R) is indicated in the EU 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. [2] The use of Multaq(R) 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(R)
is not recommended in these patients.
Multaq(R) is currently available in the U.S., Canada,
Switzerland, Germany, Denmark, Ireland, Norway and Finland and is
being launched in most European countries in 2010.
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  and in New
York .
About NICE
The National Institute for Health and Clinical Excellence (NICE)
is the independent organization in the United Kingdom responsible for
providing national guidance on the promotion of good health and the
prevention and treatment of ill health. NICE produces guidance on the
use of new and existing medicines, treatments and procedures within
the UK National Health Service (NHS). NICE technology appraisal
recommendations are prepared by independent advisory committees
called Technology Appraisal Committees, which issue an Appraisal
Consultation Document (ACD). The NHS is legally obliged to fund
(reimburse) and resource medicines and treatments recommended by
NICE's technology appraisals.
    About the NICE process for Multaq(R)
    - The stakeholder consultation period for this ACD closes on
      22 April
    - Stakeholder comments submitted to NICE on this ACD will be
      considered at the Appraisal Committee Meeting on 26 May
    - If a Final Appraisal Determination (FAD) is produced
      following the Appraisal Committee Meeting it would be expected in early
      July
    - If the FAD is not appealed, publication of Final Guidance
      would be expected sometime between July and September.
1. This new appraisal document is not the final NICE guidance on
Multaq(R). A consultation period is ongoing until April 22nd, 2010.
The appraisal committee will meet again to consider the evidence on
May 26, 2010. After this meeting the Committee will prepare the final
appraisal determination (FAD) for Multaq(R).
Forward-Looking Statement
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 projections and estimates and their
underlying assumptions, statements regarding plans, objectives,
intentions and expectations with respect to future financial results,
events, operations, services, product development and potential 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 EMA, 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, the Group's ability to benefit from external growth
opportunities 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, 2009. 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] Hohnloser S.H, Crijns H.J.G.M., van Eickels M, et al. Effect
of Dronedarone on Cardiovascular Events in Atrial Fibrillation, N
Engl J Med 2009; 360:668-78.
[2] European Medicines Agency. European Public Assessment Report.
Doc. Ref.: EMA/625172/2009; EMEA/H/C/1043

Contact:

CONTACT: Media Contact: Ingrid Gorg-Armbrecht, +33-1-53-77-46-25
or+33-6-38-10-50-87, ingrid.goerg-armbrecht@sanofi-aventis.com

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