Sanofi: FDA advisory committee votes on Zynquista(TM) (sotagliflozin) as treatment for adults with type 1 diabetes
January 17 2019 - 05:19PM
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 |
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
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that forward-looking information and statements are subject to
various risks and uncertainties, many of which are difficult to
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cause actual results and developments to differ materially from
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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, to
complete related transactions 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, 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. |
Press release (PDF)
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Source: Sanofi via Globenewswire
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