- First new treatment option in over 20 years for condition affecting
250,000 Canadians -
LAVAL, QC, Aug. 12 /CNW/ - Sanofi-aventis Canada announced today that
Multaq (dronedarone, 400 mg tablets) has received Health Canada approval for
the treatment of patients with a history of, or current atrial fibrillation to
reduce their risk of cardiovascular hospitalization due to this condition.
This approval marks the only new treatment for the management of atrial
fibrillation to come to market in two decades, and the only antiarrhythmic
drug ever with proven clinical results to reduce cardiovascular
hospitalization in patients with this serious heart-related illness.
"What's unique about the outcome data we have with Multaq is that it will
likely make us think differently about the way we manage atrial fibrillation
in the future," said Dr. Stuart Connolly, Director, Division of Cardiology,
McMaster University in Hamilton, who was the co-principal investigator in
ATHENA, the key pivotal study evaluating Multaq. "We now have a new treatment
option that goes beyond what has been available up until now thanks to
Multaq's ability to decrease hospitalizations. For patients, this is
significant because their quality of life will be enhanced if we can keep them
out of the hospital setting."
In the ATHENA study, the largest clinical trial ever conducted in
patients with atrial fibrillation, Multaq 400 mg BID reduced the combined
endpoint of risk of cardiovascular hospitalization or death from any cause by
24 per cent. The trial, published in the New England Journal of Medicine in
February 2009, enrolled 4,628 patients followed for up to 30 months (median:
22 months), 2,300 of whom received Multaq on top of standard therapy. A total
of 27 Canadian sites and 148 patients were involved.
"Multaq represents a major therapeutic advancement in atrial
fibrillation," said Hugh O'Neill, President and CEO of sanofi-aventis Canada.
"Patients will now be able to benefit from the years of research that have
gone into the development of this product. We are very pleased that we can
offer innovative solutions that will not only benefit patients and enhance
their quality of life but also help reduce the stress on our already
overburdened healthcare system."
Multaq fills an unmet medical need in the management of atrial
fibrillation, as the antiarrhythmic drugs currently used to treat this chronic
condition have many limitations due to their side effects. Because of Multaq's
favourable safety profile, it can be initiated in an outpatient setting,
making it easy for patients and physicians to use.
The medical and financial burden of atrial fibrillation in Canada
Atrial fibrillation is a potentially life-threatening condition that
places a significant burden on patients, healthcare providers, hospitals and
our healthcare system. For patients with atrial fibrillation, the risk of
mortality is increased two-fold, the risk of heart failure by two- to
three-fold, and the risk of stroke by up to five-fold.
For every 100,000 people in the population, 194 are hospitalized each
year due to atrial fibrillation. This represents more than 43,000
hospitalizations each year in Canada.(1) The average cost of hospitalization
for arrhythmia in Ontario, for example, is $5,161 per event, bringing the
annual hospitalization cost in that province alone to $84.2 million.(2) This
would translate into annual hospitalization costs of $222.5 million if
extrapolated to the entire country.
"We know that 15 per cent of all strokes are due to atrial fibrillation,"
said Dr. Connolly. "These strokes are typically more severe and often leave
patients with serious after-effects. This has a huge impact not only on the
patients themselves, but on their caregivers and the healthcare system as a
Increasing prevalence of atrial fibrillation
Atrial fibrillation is the most common form of arrhythmia and is more
frequent in men than women across all age groups. Because atrial fibrillation
affects primarily people over the age of 45 - the baby boomer generation - the
numbers have only one way to go, and that's up, according to the Heart &
Stroke Foundation of Canada. The incidence is growing worldwide in tandem with
the aging population, and the condition is being recognized as an emerging
public health concern. Atrial fibrillation affects 2.5 million people in the
United States and 4.5 million people in the European Union. In Canada,
approximately 250,000 are affected.
Currently, three per cent of the population over the age of 45 and six
per cent over the age of 65 have atrial fibrillation. The risk of developing
this condition increases with age; after 55, its incidence doubles with each
decade of life.
About Multaq (dronedarone)
Multaq was discovered and developed by sanofi-aventis. Its efficacy and
safety were evaluated in more than 6,000 patients. The most frequently
observed adverse reactions in a clinical setting were diarrhea, nausea,
abdominal pain, vomiting, asthenia (weakness) and cutaneous rash.
Multaq is contraindicated in patients with severe congestive heart
failure (classified as Stage IV by the NYHA or New York Heart Association) and
other unstable hemodynamic (cardiovascular) conditions, and should be used
with caution in patients with moderate congestive heart failure (NYHA Stage
III). Full prescribing information is contained in the product monograph.
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
Sanofi-aventis is represented in Canada by the pharmaceutical company
sanofi-aventis Canada Inc., based in Laval, Quebec, and by the vaccines
company Sanofi Pasteur Limited, based in Toronto, Ontario. Together they
employ more than 2,000 people and are leaders in Canada's biopharmaceutical
sector, a critical research-based industry that generates jobs, business and
opportunity throughout the country.
Video News Release will be available via satellite Wednesday, August 12,
10:00 -10:30 Eastern Standard Time and again at 14:00 -14:30 Eastern
SATELLITE FEED COORDINATES:
Anik F2, C-Band, Transponder 3B @111.1 West
Vertical Polarization, D/L Freq. 3820MHz.
Audio subcarriers 6.8 left, 6.2 right
For assistance with the feed call: 1-800-565-1471
1. Humphries et al.
2. Ontario Case Costing Initiative, http://www.occp.com, CMG 237,
Accessed June 2009.
For further information:
For further information: Christian Marcoux, sanofi-aventis Canada, (514)
956-4275, Christian.Marcoux@sanofi-aventis.com; Valerie Cameron, MS&L, (416)