PARIS, June 8, 2015 /PRNewswire-USNewswire/
-- Sanofi announced today the presentation of full results of
the Phase IIIb ELIXA study, which was designed to assess the
cardiovascular (CV) safety of Lyxumia® (lixisenatide) in
adults with type 2 diabetes and high CV risk. As previously
reported, lixisenatide met the pre-specified criterion of
non-inferiority versus placebo for the composite primary endpoint
of CV death, non-fatal myocardial infarction, non-fatal stroke and
hospitalization for unstable angina but did not demonstrate
superiority. The full results will be included in the U.S. New Drug
Application for lixisenatide, which is on track to be resubmitted
to the U.S. Food and Drug Administration in Q3 2015.
Additional safety findings include no signal for increased risk
of heart failure, pancreatitis, pancreatic cancer or severe
symptomatic hypoglycemia. Lixisenatide was generally safe and well
tolerated; nausea and emesis (vomiting), which are known side
effects of the GLP-1 RA class, were observed more frequently with
lixisenatide.
"The importance of determining the CV safety of diabetes
medicines, as set out in the FDA guidance issued in 2008, is widely
recognized. People around the world are being treated with GLP-1
receptor agonists, and the CV effects were unknown," said Dr.
Marc Pfeffer, Professor of Medicine
at Harvard Medical School, Senior
Physician in the Division of Cardiovascular Medicine at Brigham and
Women's Hospital and Chair of the ELIXA Steering Committee.
"ELIXA goes beyond the FDA guidance to deliver data related to
heart failure and other insights that are not currently available
for any other GLP-1 receptor agonist. Our data provide the medical
community, patients and caregivers with information that will
better inform them about how lixisenatide can be safely used to
better control their glucose."
"As the first completed long-term CV safety study of a
GLP-1 receptor agonist, the successful ELIXA trial will be shared
with health authorities around the world and provides important
outcomes data that can be considered by healthcare
professionals," said Pierre Chancel, Senior Vice President,
Head of Global Diabetes at Sanofi. "Sanofi is committed to
developing and delivering safe and effective treatment options for
people with diabetes. This study supports that important
work."
Full study results were presented today during a symposium at
the American Diabetes Association 75th Scientific Sessions in
Boston.
Results of Analysis
Lixisenatide met the pre-specified
criterion of non-inferiority versus placebo for the composite
primary endpoint of MACE+: CV death, non-fatal
myocardial infarction, non-fatal stroke and hospitalization for
unstable angina (Hazard Ratio [95% CI]: 1.017 [0.886 to 1.168]).
Since the upper bound of the 95% CI was greater than 1.0,
superiority over placebo in reducing the composite primary endpoint
was not met.
The CV safety of lixisenatide was also confirmed by further
analyses (e.g. MACE Hazard Ratio [95% CI]: 1.02 [0.887 to 1.172]).
No signal for increased risk of heart failure (HF) was observed
(Hazard Ratio [95% CI]: 0.96 [0.75 to 1.23]).
Measures of non-CV safety showed pancreatitis (0.2% with
lixisenatide and 0.3% with placebo), pancreatic cancer (<0.1%
with lixisenatide and 0.3% with placebo), severe symptomatic
hypoglycemia (0.3 events per 100 patient-years with lixisenatide;
0.6 per 100 patient-years with placebo), malignancy (2.9% with
lixisenatide and 2.6% with placebo), drug-related allergic
reactions (0.2% with both lixisenatide and
placebo).
Conference Call on
Diabetes for the Financial Community
|
Sanofi will host an
IR Thematic Conference Call on Diabetes for the financial community
in connection with the upcoming American Diabetes Association's
Scientific Sessions.
The call/webcast will
take place on Tuesday June 9th, 2015 at:
2 pm Paris (CEST) / 1
pm London (BST) / 8 am New York (EDT) / 5 am San Francisco
(PDT)
The conference call
will include a presentation followed by a Q&A
session.
It will be accessible
through audio webcast at www.sanofi.com and via the following
telephone numbers:
France +33 (0) 1 70 77 09 40
UK +44 (0) 203 367
9453
US +1 866 907 59
28
REPLAY
NUMBERS
France +33 (0) 1 72 00 15 00
UK +44 (0) 203 367
9460
US +1 877 64 230
18
CONFERENCE CODE
293697#
|
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 most EU
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.
Lixisenatide is an investigational product in the U.S. It will be
resubmitted to the Food & Drug Administration (FDA) in the
third quarter of 2015. 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 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).
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generally beyond the control of Sanofi, that could cause actual
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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
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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
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average number of shares outstanding as well as those discussed or
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Sanofi, including those listed under "Risk Factors" and "Cautionary
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