PARIS, May 25, 2016 /PRNewswire/ -- Sanofi
announced today that the Endocrinologic and Metabolic Drugs
Advisory Committee (EMDAC) of the U.S. Food and Drug Administration
(FDA) recommended the approval of the New Drug Application (NDA)
for the investigational fixed-ratio combination of basal insulin
glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide for
the treatment of adults with type 2 diabetes. The 15-member panel
voted 12 to 2 (1 panelist did not vote due to travel) to approve
the fixed-ratio combination of basal insulin glargine 100 Units/mL
and GLP-1 receptor agonist lixisenatide.
"We are pleased by the Advisory Committee's
recommendation for approval of this investigational diabetes
therapy," said Elias Zerhouni, President, Global R&D,
Sanofi. "By combining the complementary therapeutic effects of
insulin glargine on fasting plasma glucose and of lixisenatide on
postprandial plasma glucose, both of which can contribute to HbA1c
lowering, this fixed-ratio product may address some of the unmet
needs of adults living with type 2 diabetes who are considering
initiating or intensifying insulin. We look forward to continuing
to work with the FDA as it completes its reviews of these New Drug
Applications."
The NDA submission for the fixed-ratio combination of basal
insulin glargine 100 Units/mL and GLP-1 receptor agonist
lixisenatide is based on data from two Phase 3 studies, which
enrolled more than 1,900 adults worldwide to evaluate the efficacy
and safety of the fixed-ratio combination of basal insulin glargine
100 Units/mL and GLP-1 receptor agonist lixisenatide when used in
patient populations insufficiently controlled after oral
antidiabetic agents (OADs) and after basal insulin therapy,
respectively. Both studies met their primary endpoints. The full
results of both studies will be presented in June 2016 at the American Diabetes Association's
76th Scientific Sessions.
The NDA submission for lixisenatide is based on results from the
GetGoal clinical program, which included 13 clinical trials
involving more than 5,000 adults with type 2 diabetes. The NDA
submission for lixisenatide also includes findings from the ELIXA
study, a long-term cardiovascular (CV) outcomes study in adults
with type 2 diabetes and high CV risk (i.e., patients who have
recently experienced a spontaneous acute coronary syndrome
event).
Lixisenatide and the fixed-ratio combination of basal insulin
glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide are
undergoing FDA review, with decisions anticipated in July and
August 2016, respectively. The
proprietary names for both compounds in the U.S. are
under consideration. Lixisenatide is currently approved in more
than 60 countries worldwide under the proprietary name
Lyxumia®. The fixed-ratio combination of basal insulin
glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide was
submitted for regulatory review in the European Union in
March 2016 and has not yet been
approved for use by any health authority.
About Sanofi Diabetes & Cardiovascular
Diabetes and cardiovascular disease affect millions of people
worldwide, with many managing the complex challenges of both.
Building on our portfolio evolution, heritage and expertise, Sanofi
has a focused business unit dedicated to delivering innovative,
value-based medicines and integrated solutions in these therapeutic
areas. We are committed to a collaborative approach that involves
strategic alliances with professional and patient associations,
research institutions and leaders in healthcare and other
industries, with the goal of advancing scientific knowledge,
driving the convergence of science and technology, helping to
improve outcomes and inspiring an evolution in care.
About Sanofi
Sanofi, a global healthcare leader,
discovers, develops and distributes therapeutic solutions focused
on patients' needs. Sanofi is organized into five global business
units: Diabetes and Cardiovascular, General Medicines and Emerging
Markets, Sanofi Genzyme, Sanofi Pasteur and Merial. Sanofi is
listed in Paris (EURONEXT: SAN)
and in New York (NYSE: SNY).
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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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Contacts:
Media Relations
Jack Cox
Tel.: + (33) 1 53 77 46 46
mr@sanofi.com
Investor Relations
George Grofik
Tel.: + (33) 1 53 77 45 45
ir@sanofi.com
Global Diabetes Communications
Philip McNamara
Tel.: +1 908 981 5497
philipmcnamara@sanofi.com
U.S. Diabetes Communications
Susan Brooks
Tel.: +1 908 981 6566
susan.brooks@sanofi.com
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SOURCE Sanofi