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FDA Approves Multaq(R) for Patients With Atrial Fibrillation or Atrial Flutter

Paris (ots/PRNewswire)

  • Multaq(R) Approved to Reduce the Risk of Cardiovascular Hospitalization in Patients With Atrial Fibrillation or Atrial Flutter
  • U.S Commercial Launch Planned for the Summer of 2009
Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that
the U.S. Food and Drug Administration (FDA) has approved Multaq(R)
(dronedarone) 400 mg Tablets. Patients with atrial fibrillation (AF)
or atrial flutter (AFL) soon will have a new treatment option to help
improve current management of their disease. Multaq(R) is the first
drug approved in the United States that has shown a clinical benefit
to reduce cardiovascular hospitalization in patients with AF/AFL.
Multaq(R) is an anti-arrhythmic indicated to reduce the risk of
cardiovascular hospitalization in patients with paroxysmal or
persistent atrial fibrillation (AF) or atrial flutter (AFL), with a
recent episode of AF/AFL and associated cardiovascular risk factors,
who are in sinus rhythm or who will be cardioverted. Associated
cardiovascular risk factors include age over 70 years, hypertension,
diabetes, prior cerebrovascular accident, left atrial diameter
greater than or equal to 50 mm or left ventricular ejection  fraction
[LVEF] <40%. The FDA approval is based on five international,
multi-center, randomized clinical trials involving nearly 6,300
patients.
"The FDA approval of Multaq(R) is an important milestone in the
management of atrial fibrillation or atrial flutter that demonstrates
the commitment of sanofi-aventis to provide patients and physicians
with important new medicines in therapeutic areas with significant
healthcare needs," said Christopher A. Viehbacher, Chief Executive
Officer of sanofi-aventis. "Sanofi-aventis is proud of its ability to
bring innovative therapies to market and contribute to reducing the
public health burden of atrial fibrillation."
The landmark ATHENA trial evaluated the efficacy and safety of
Multaq(R) in patients with AF/AFL or a recent history of these
conditions (71% of these patients had no heart failure, 29% were in
NYHA class I-III with stable heart failure). This trial showed that
Multaq(R) (dronedarone) 400 mg BID, 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.
This reduction was generally consistent across study subgroups
based on baseline characteristics or medications. Patients taking
Multaq(R) had higher rates of diarrhea, nausea, bradycardia,
QT-interval prolongation and cutaneous rash than patients taking
placebo.
Initiation of Multaq(R) treatment is contraindicated in patients
with severe heart failure (NYHA class IV) or NYHA Class II - III
heart failure with a recent decompensation requiring hospitalization
or referral to a specialized heart failure clinic. This unstable
population corresponds to the population of the ANDROMEDA trial in
which patients receiving dronedarone had a greater than 2-fold
increase in mortality compared to placebo.
The ATHENA and ANDROMEDA trials provided two sets of data
supporting the assessment of the product's benefit risk ratio in two
significantly different patient populations.
To ensure the use of Multaq(R) in the appropriate patient
population, sanofi-aventis U.S. LLC also announced the launch of
mPACT(TM) - Multaq(R) Partnership for Appropriate Care and Treatment
- the Risk Evaluation and Mitigation Strategy (REMS) developed by
sanofi-aventis U.S. LLC. The mPACT(TM) Partnership was developed to
assist healthcare professionals (HCPs) with the identification of
appropriate patients and to ensure the safe use of Multaq(R) while
minimizing risk. The risk mitigation program consists of a
Communication Plan for HCPs, a medication guide for patients and
post-marketing surveillance.
"We are pleased that the FDA has granted approval of Multaq(R)
for patients in a therapeutic area that has seen few new treatment
options in the last twenty years," said Marc Cluzel, MD, Senior Vice
President, Research and Development, sanofi-aventis. "Sanofi-aventis'
commitment to research and development in this area is rewarded
today, and we hope it will benefit many patients suffering from this
disease."
The incidence of atrial fibrillation is growing worldwide in
relation to aging populations. It is emerging as a public health
concern and affects about 2.5 million people in the United States and
4.5 million people in the European Union. Atrial fibrillation is a
potentially life-threatening condition, with significant burden on
patients, health care providers and payers.
"It is exciting that Multaq(R) will now be available as a
treatment option for patients with paroxysmal or persistent atrial
fibrillation or atrial flutter," said Stuart Connolly, M.D.,
Professor of Medicine & Director, Division of Cardiology, McMaster
University, Hamilton, Canada, and co-principal investigator in the
ATHENA study. "Based on clinical studies, Multaq(R) reduces the risk
of cardiovascular hospitalizations in patients with atrial
fibrillation / atrial flutter, this outcome could change the way we
approach the management of the disease."
Multaq(R) is to be given twice daily as a 400 mg tablet and
should be taken as one tablet with the morning and evening meals.
Treatment with Multaq(R) can be initiated in an outpatient setting.
Most common adverse reactions are diarrhea, nausea, vomiting,
abdominal pain, asthenia (weakness) and cutaneous rash.
A registration dossier of Multaq(R) is also under regulatory
review by the European Medicines Agency (EMEA).
About dronedarone (Multaq(R))
Multaq(R), discovered and developed by sanofi-aventis, is one of
the major therapeutic innovations in patients with atrial
fibrillation in the last twenty years.
The efficacy and safety of Multaq(R) 400 mg twice daily was
evaluated in five controlled studies, ATHENA, ANDROMEDA, EURIDIS,
ADONIS, and DAFNE, involving nearly 6,300 patients including more
than 3200 patients who received Multaq(R).
The ATHENA trial, which involved 4,628 patients with AF or AFL
and more than 2,300 patients receiving Multaq(R) on top of standard
therapy, demonstrated a 24% reduction in time to first CV
hospitalization or all-cause mortality (P<0.001) compared with
placebo meeting the primary endpoint.
The ANDROMEDA study, was terminated prematurely after enrolment
of 627 of 1000 planned patients with congestive heart failure, in
relation to excess mortality due to worsening heart failure in the
dronedarone group [n=25 versus 12 (placebo), p=0.027].
The patient population enrolled in the ANDROMEDA and ATHENA
studies was significantly different. The patients enrolled in
ANDROMEDA had relatively severe heart failure and had been
hospitalized, or referred to a specialty heart failure clinic for
worsening symptoms. Patients were predominantly NYHA II and III (New
York Heart Association classification) and only 25% had a history of
AF/AFL at randomization. In contrast, in ATHENA, all patients had a
history of AF/AFL, and 71% of patients had no heart failure, 25% were
NYHA class I or II, and only 4% were class III.
The ANDROMEDA and ATHENA trials were published in the New England
Journal of Medicine (NEJM) respectively in 2008 and 2009.
Important Safety Information
Multaq(R) is contraindicated in patients with NYHA Class IV heart
failure or NYHA Class II-III heart failure with a recent
decompensation requiring hospitalization or referral to a specialized
heart failure clinic. In a placebo-controlled study in patients with
severe heart failure requiring recent hospitalization or referral to
a specialized heart failure clinic for worsening symptoms (the
ANDROMEDA study), patients given dronedarone had a greater than
two-fold increase in mortality. Such patients should not be given
dronedarone.
Multaq(R) is also contraindicated in second- or third-degree
atrioventricular (AV) block or sick sinus syndrome (except when used
in conjunction with a functioning pacemaker), bradycardia <50 bpm,
QTc Bazett interval greater than or equal to 500 ms and severe
hepatic impairment.
Multaq(R) should not be given to patients who are or may become
pregnant (Category X) or nursing.
Multaq(R) should not be coadministered with strong CYP 3A
inhibitors or medicinal products that prolong the QT interval.
In patients with new or worsening heart failure, the suspension
or discontinuation of Multaq(R) should be considered.
Serum creatinine levels increase by about 0.1mg/dL following
Multaq(R) treatment initiation. The elevation has a rapid onset,
reaches a plateau after 7 days and is reversible after
discontinuation.
Hypokalemia and hypomagnesemia may occur with concomitant
administration of potassium-depleting diuretics. Potassium levels
should be maintained in the normal range pre and during
administration.
For full prescribing information, please visit
http://products.sanofi-aventis.us/Multaq/Multaq.pdf
About Atrial Fibrillation/Atrial Flutter
Atrial fibrillation is the leading cause of hospitalization for
arrhythmia in the U.S. and represents one-third of hospitalizations
for arrhythmia in Europe. Hospitalization associated with AF has
increased dramatically (two-to-three fold) in recent years in the
U.S. Atrial fibrillation is a complex disease that increases the risk
of stroke up to five-fold, worsens the prognosis of patients with
cardiovascular risk factors, and doubles the risk of mortality.
Atrial flutter, another type of arrhythmia generating in the atrium,
occurs less frequently, and may evolve into atrial fibrillation.
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 INFORMATIONS PLEASE VISIT:
Multimedia News Release:
http://www.prnewswire.com/mnr/multaq/37750/
Dronedarone press office:
http://www.dronedarone-atrial-fibrillation-pressoffice.com

Contact:

MEDIA CONTACT: Corporate, Philippe BARQUET, Tel: +33(0)6-70-48-61-28,
Email: philippe.barquet@sanofi-aventis.com; US, Marisol PERON, Tel:
+1-908-981-6565, Mobile: +1-908-672-9051, Email:
marisol.peron@sanofi-aventis.com

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