Sanofi: FDA Advisory Committee Recommends Approval of Sanofi Treatment for Adults with Type 2 Diabetes
(Thomson Reuters ONE) -
FDA Advisory Committee Recommends Approval of Sanofi Treatment for Adults with
Type 2 Diabetes
- FDA decisions on the investigational fixed-ratio combination of basal insulin
glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide and
investigational lixisenatide anticipated in Q3 2016 -
Paris, France - May 25, 2016 - 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 76(th) 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).
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 initiatives 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, 2015.
Other than as required by applicable law, Sanofi does not undertake any
obligation to update or revise any forward-looking information or statements.
Contacts:
Media Relations Investor Relations
Jack Cox George Grofik
Tel.: + (33) 1 53 77 46 46 Tel.: + (33) 1 53 77 45 45
mr(at)sanofi.com ir(at)sanofi.com
Global Diabetes Communications U.S. Diabetes Communications
Philip McNamara Susan Brooks
Tel.: +1 908 981 5497 Tel.: +1 908 981 6566
philipmcnamara(at)sanofi.com susan.brooks(at)sanofi.com
Press release:
http://hugin.info/152918/R/2015403/747404.pdf
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originality of the information contained therein.
Source: Sanofi via GlobeNewswire
[HUG#2015403]
Unternehmensinformation / Kurzprofil:
Datum: 26.05.2016 - 00:21 Uhr
Sprache: Deutsch
News-ID 473742
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