BRIDGEWATER, N.J.
and THE WOODLANDS, Texas,
May 22, 2018
/PRNewswire/ -- The U.S. Food and Drug Administration (FDA)
has accepted Sanofi's regulatory filing for Zynquista
(sotagliflozin). The investigational oral treatment would be used
in addition to insulin therapy to improve blood sugar control in
adults with type 1 diabetes.
"If approved, Zynquista
would be the first oral antidiabetic drug approved in the U.S. for
use by adults with type 1 diabetes, in combination with insulin."
says Jorge Insuasty, Senior-Vice
President, Global Head of Development, Sanofi. "We look forward to
working with the FDA through the review process with a view towards
bringing this investigational medicine to adults with type 1
diabetes in the U.S."
Developed in partnership with Lexicon Pharmaceuticals,
Inc., Zynquista is an investigational oral dual inhibitor of SGLT-1
and SGLT-2, proteins that influence how the intestines and kidneys
absorb and eliminate sugar (glucose) resulting in improved glucose
control and additional clinical benefits.
"After decades of little
change and innovation, the treatment of type 1 diabetes has begun
to shift significantly and, if approved, our dual SGLT-1 and SGLT-2
inhibitor, Zynquista, would be the first approved oral therapy used
in combination with insulin to improve glycemic control and patient
outcomes for adults in the United
States who are living with type 1 diabetes," said
Pablo Lapuerta, M.D., executive vice
president and chief medical officer, Lexicon. "The acceptance of
the NDA filing moves us closer to providing a meaningful option for
people with type 1 diabetes and we look forward to continuing to
work closely with the FDA during the review
process."
The FDA New Drug Application for sotagliflozin is based on
data from the inTandem clinical trial program which includes three
Phase 3 clinical trials assessing the safety and efficacy of
Zynquista in approximately 3,000 adults with inadequately
controlled type 1 diabetes.1–3 The safety and efficacy data have
not yet been evaluated by any regulatory authority.
The target FDA action date under the Prescription Drug
User Fee Act (PDUFA) is anticipated to be March 22, 2019. Sanofi also submitted a
regulatory application to the European Medicines Agency earlier
this year.
About Sanofi
Sanofi (EURONEXT: SAN) (NYSE: SNY) is dedicated to
supporting people through their health challenges. We are a global
biopharmaceutical company focused on human health. We prevent
illness with vaccines, provide innovative treatments to fight pain
and ease suffering. We stand by the few who suffer from rare
diseases and the millions with long-term chronic
conditions.
With more than 100,000 people in 100 countries, Sanofi is
transforming scientific innovation into healthcare solutions around
the globe.
Sanofi, Empowering Life
About Lexicon Pharmaceuticals
Lexicon (NASDAQ: LXRX) is a fully integrated
biopharmaceutical company that is applying a unique approach to
gene science based on Nobel Prize-winning technology to discover
and develop precise medicines for patients with serious, chronic
conditions. Through its Genome5000™ program, Lexicon scientists
have studied the role and function of nearly 5,000 genes over the
last 20 years and have identified more than 100 protein targets
with significant therapeutic potential in a range of diseases.
Through the precise targeting of these proteins, Lexicon is
pioneering the discovery and development of innovative medicines to
safely and effectively treat disease. In addition to its first
commercial product, XERMELO® (telotristat ethyl), Lexicon has a
pipeline of promising drug candidates in clinical and pre-clinical
development in diabetes and metabolism and neuropathic pain. For
additional information please visit
www.lexpharma.com.
Sanofi Media Relations
Contact Ashleigh
Koss Tel.: +1
908-981-8745 mr@sanofi.com
Lexicon Media Relations
Contact Chas
Schultz Tel.:
281-863-3421 cschultz@lexpharma.com
|
Investor Relations Contact George
Grofik
Tel.: +33 (0)1 53 77 45 45
ir@sanofi.com
Lexicon Investor Relations
Contact Kimberly
Lee, D.O. Tel:
281-863-3383
klee@lexpharma.com
|
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 regarding the potential marketing approvals for the
product. Forward-looking statements are generally identified by the
words "expects", "anticipates", "believes", "intends", "estimates",
"plans", "will be" 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, including future clinical data relating to the product
,decisions by regulatory authorities, such as the FDA or the EMA,
regarding whether and when to approve the product as well as
their decisions regarding labeling and other matters that could
affect the availability or commercial potential of the product, the
absence of guarantee that the product if approved will be
commercially successful, , risks associated with intellectual
property, future litigation, the future approval and commercial
success of therapeutic alternatives, and volatile economic
conditions, as well as those risks 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,
2017. Other than as required by applicable law, Sanofi does
not undertake any obligation to update or revise any
forward-looking information or statements.
Lexicon Safe Harbor Statement
This press release contains "forward-looking statements,"
including statements relating to Lexicon's and Sanofi's clinical
development of and regulatory filings for Zynquista (sotagliflozin)
and the potential therapeutic and commercial potential of
Zynquista. In addition, this press release also contains
forward-looking statements relating to Lexicon's growth and future
operating results, discovery, development and commercialization of
products, strategic alliances and intellectual property, as well as
other matters that are not historical facts or information. All
forward-looking statements are based on management's current
assumptions and expectations and involve risks, uncertainties and
other important factors, specifically including the risk that the
FDA and other regulatory authorities may not grant regulatory
approval of Zynquista in accordance with Lexicon\'s currently
anticipated timelines or at all, and the risk that such regulatory
approvals, if granted, may have significant limitations on the
approved use of Zynquista. As a result, Zynquista may never be
successfully commercialized. Other risks include Lexicon's ability
to meet its capital requirements, successfully commercialize
XERMELO (telotristat ethyl), successfully conduct preclinical and
clinical development and obtain necessary regulatory approvals of
LX2761, LX9211 and its other potential drug candidates on its
anticipated timelines, achieve its operational objectives, obtain
patent protection for its discoveries and establish strategic
alliances, as well as additional factors relating to manufacturing,
intellectual property rights, and the therapeutic or commercial
value of its drug candidates. Any of these risks, uncertainties and
other factors may cause Lexicon's actual results to be materially
different from any future results expressed or implied by such
forward-looking statements. Information identifying such important
factors is contained under "Risk Factors" in Lexicon's annual
report on Form 10-K for the year ended December 31, 2017, as filed with the Securities
and Exchange Commission. Lexicon undertakes no obligation to update
or revise any such forward-looking statements, whether as a result
of new information, future events or otherwise.
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SOURCE Sanofi