PARIS, March 19, 2015 /PRNewswire/ -- Sanofi
announced today top-line results of the Phase IIIb ELIXA
cardiovascular outcomes study, which compared lixisenatide to
placebo in a high-risk population of adults with type 2 diabetes
evaluating cardiovascular safety. The study showed that
lixisenatide was non-inferior, although not superior, to placebo
for cardiovascular safety.
ELIXA full results will be presented Monday, June 8, 2015, at the American Diabetes
Association 75th Scientific Sessions in Boston by the ELIXA steering committee,
chaired by Dr. Marc Pfeffer. The
results will also be included in the U.S. New Drug Application of
lixisenatide, which is on track to be resubmitted to the U.S. Food
and Drug Administration in the third-quarter of 2015. Lixisenatide
is not approved in the United
States.
"The completion of the ELIXA study is a significant milestone
for lixisenatide, which is the first
GLP-1 receptor agonist with long-term cardiovascular safety data in
people with diabetes who have high cardiovascular risk," said
Dr. Elias Zerhouni, President,
Global R&D at Sanofi. "Sanofi looks forward to submitting
the results to health authorities worldwide."
About ELIXA
ELIXA (Evaluation of Cardiovascular
Outcomes in Patients With Type 2 Diabetes After Acute Coronary
Syndrome During Treatment With Lixisenatide) is the first
event-driven cardiovascular outcomes study to provide data for a
glucagon-like peptide-1 receptor agonist (GLP-1 RA). ELIXA was a
randomized, double-blind, parallel group trial designed to evaluate
cardiovascular risk, comparing lixisenatide to placebo in a
high-risk population of adults with type 2 diabetes. More than
6,000 adults with type 2 diabetes and high CV risk (i.e., patients
who have recently experienced a spontaneous acute coronary syndrome
event) participated in the trial. The composite primary endpoint,
which was evaluated for non-inferiority and superiority, comprised
cardiovascular (CV) death, non-fatal myocardial infarction,
non-fatal stroke, or hospitalization for unstable angina. The
global ELIXA study started in June
2010 and was completed in 2015.
About Lixisenatide
Lixisenatide is a once-daily
prandial glucagon-like peptide-1 receptor agonist (GLP-1 RA) for
the treatment of adult patients with type 2 diabetes mellitus.
GLP-1 is a naturally-occurring peptide hormone that is released
within minutes after eating a meal. It is known to suppress
glucagon secretion from pancreatic alpha cells and stimulate
glucose-dependent insulin secretion by pancreatic beta cells.
Lixisenatide was in-licensed from Zealand Pharma A/S (NASDAQ OMX
Copenhagen: ZEAL), www.zealandpharma.com, and was approved in
Europe in 2013 for the treatment
of adults with type 2 diabetes mellitus to achieve glycemic control
in combination with oral glucose-lowering medicinal products and/or
basal insulin when these, together with diet and exercise, do not
provide adequate glycemic control. Lixisenatide is currently
approved in over 50 countries worldwide for the treatment of adults
with type 2 diabetes, with commercial launches in some European
countries, Japan, Brazil, Mexico and other markets. Lyxumia is the
proprietary name approved by the European Medicines Agency and
other health authorities for the GLP-1 RA lixisenatide. The
proprietary name in the U.S. is under consideration.
About Sanofi Diabetes
Sanofi strives to help people
manage the complex challenge of diabetes by delivering innovative,
integrated and personalized solutions. Driven by valuable insights
that come from listening to and engaging with people living with
diabetes, the Company is forming partnerships to offer diagnostics,
therapies, services, and devices including blood glucose monitoring
systems. Sanofi markets injectable, inhaled and oral medications
for people with type 1 or type 2 diabetes.
About Sanofi
Sanofi, a global healthcare leader,
discovers, develops and distributes therapeutic solutions focused
on patients' needs. Sanofi has core strengths in the field of
healthcare with seven growth platforms: diabetes solutions, human
vaccines, innovative drugs, consumer healthcare, emerging markets,
animal health and Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Sanofi 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 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's 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, 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 product candidates, the absence of guarantee that the
product 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,
trends in exchange rates and prevailing interest rates, the impact
of cost containment policies and subsequent changes thereto, the
average number of shares outstanding as well as those discussed or
identified in the public filings with the SEC and the AMF made by
Sanofi, including those listed under "Risk Factors" and "Cautionary
Statement Regarding Forward-Looking Statements" in Sanofi's annual
report on Form 20-F for the year ended December 31, 2014. Other than as required by
applicable law, Sanofi does not undertake any obligation to update
or revise any forward-looking information or statements.
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SOURCE Sanofi