Sanofi: FDA advisory committee votes on Zynquista(TM) (sotagliflozin) as treatment for adults with type 1 diabetes
January 17 2019 - 05:20PM
FDA advisory committee votes on Zynquista(TM) (sotagliflozin)
as treatment for adults with type 1 diabetes
PARIS and THE WOODLANDS, TX - January 17,
2019 - The Endocrinologic and Metabolic Drugs Advisory
Committee of the U.S. Food and Drug Administration (FDA) today
voted eight to eight on the question of whether the overall
benefits of Zynquista(TM)* (sotagliflozin) outweighed the risks to
support approval. Sotagliflozin is an investigational oral dual
SGLT1 and SGLT2 inhibitor under regulatory review as an adjunct to
insulin for the treatment of adults with type 1 diabetes (T1D).
While the FDA is not required to follow the committee's vote, the
agency considers the committee's recommendations when making its
decision, which is anticipated by March 22, 2019.
Sotagliflozin, developed by Sanofi and Lexicon,
has the potential to be the first oral antidiabetic drug approved
in the United States together with insulin therapy to improve
glycemic (blood sugar) control in adults with T1D.
"We believe in the overall benefit-risk profile
of sotagliflozin for adults with type 1 diabetes who lack adequate
glycemic control using insulin alone," said Rachele Berria, MD,
PhD, Global Vice President and Head of Diabetes Medical Affairs,
Sanofi. "We will continue to work with the FDA through its review
process to hopefully bring to patients a new treatment that can
help people living with type 1 diabetes control their blood sugar
and address some of the challenges of insulin-only therapy."
Sotagliflozin is an investigational oral dual
inhibitor of two proteins responsible for glucose regulation known
as sodium-dependent glucose co-transporter types 1 and 2 (SGLT1 and
SGLT2). SGLT1 is responsible for glucose absorption in the
gastrointestinal tract, and SGLT2 is responsible for glucose
reabsorption by the kidney. About 1.3 million Americans have T1D
and an estimated 40,000 people will be newly diagnosed each year in
the U.S., according to the American Diabetes Association.
"In clinical trials, when used in combination
with insulin therapy, sotagliflozin significantly improved glycemic
control without increasing hypoglycemia," said Pablo Lapuerta, MD,
Executive Vice President and Chief Medical Officer, Lexicon. "These
results could not be achieved with insulin alone. Diabetic
ketoacidosis is an inherent risk of type 1 diabetes and an increase
was seen with sotagliflozin compared to insulin alone. We believe
this can potentially be addressed with proper education and
monitoring."
The New Drug Application for sotagliflozin
included data from the inTandem clinical trial program, which
included three Phase 3 clinical trials assessing the safety and
efficacy of sotagliflozin in approximately 3,000 adults with
inadequately controlled T1D. The safety and efficacy data have not
yet been fully evaluated by any regulatory authority.
Sanofi also submitted a regulatory application
to the European Medicines Agency (EMA) in 2018. An EMA approval
decision is expected in the first half of 2019.
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 Kressmann Tel.: +1
732-532-5318 mr@sanofi.com Lexicon Media Relations Contact
Chas Schultz Tel.: 281-863-3421 cschultz@lexpharma.com |
Sanofi 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 |
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Forward-looking statements are statements that are not historical
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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
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Sanofi's ability to benefit from external growth opportunities, to
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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
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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 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, 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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