Sanofi: FDA issues Complete Response Letter for Zynquista(TM) (sotagliflozin)
22 Marzo 2019 - 12:16PM
FDA issues Complete Response Letter for Zynquista(TM)
(sotagliflozin)
PARIS and THE WOODLANDS, TX -
March 22, 2019 - The U.S. Food and Drug
Administration (FDA) issued a Complete Response Letter (CRL)
regarding the New Drug Application for investigational
Zynquista(TM) (sotagliflozin)*, a dual SGLT1 and SGLT2 inhibitor
for the treatment of adults with type 1 diabetes in combination
with insulin.
A CRL is a communication from the FDA that
informs companies that an application cannot be approved in its
present form.
Sanofi and Lexicon will work closely with the
FDA to determine the appropriate next steps.
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(TM) 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.
*Sotagliflozin is an investigational drug and is
under regulatory review by the European Medicines Agency (EMA) and
U.S. Food and Drug Administration (FDA). The EMA and FDA have
conditionally accepted Zynquista(TM) as the trade name for
sotagliflozin.
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 |
Sanofi Media Relations Contact Nicolas KressmannTel.: +1
732-532-5318 mr@sanofi.com Lexicon Media Relations
ContactChas Schultz Tel.: +1-281-863-3421cschultz@lexpharma.com
|
Sanofi Investor
Relations Contact George Grofik Tel.: +33 (0)1 53 77 45 45
ir@sanofi.com Lexicon Investor Relations ContactKimberly
Lee, D.O. Tel: +1 281-863-3383klee@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 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,
Sanofi's ability to benefit from external growth opportunities
and/or obtain regulatory clearances, risks associated with
intellectual property and any related pending or future litigation
and the ultimate outcome of such litigation, trends in
exchange rates and prevailing interest rates, volatile economic
conditions, 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, 2018. Other than as required by
applicable law, Sanofi does not undertake any obligation to update
or revise any forward-looking information or statements.
Lexicon Forward-Looking Statements 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, 2018, 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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