FDA to review Zynquista™ (sotagliflozin) as potential treatment for type 1 diabetes
May 22 2018 - 8:03AM
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. 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 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 ContactAshleigh KossTel.:
+1 908-981-8745mr@sanofi.com Lexicon Media Relations
ContactChas 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 StatementsThis 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
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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 StatementThis 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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