The European Medicines Agency’s Committee for Medicinal Products
for Human Use (CHMP) has adopted a positive opinion on the
Marketing Authorization of Zynquista™* (sotagliflozin), developed
by Sanofi and Lexicon.
The CHMP recommended approval of sotagliflozin
in the European Union (EU) in both a 200-mg and 400-mg dose for use
as an adjunct to insulin therapy to improve blood sugar (glycemic)
control in adults with type 1 diabetes (T1D) mellitus with a body
mass index (BMI) ≥ 27 kg/m2, who have failed to achieve adequate
glycemic control despite optimal insulin 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).1 SGLT1 is responsible for glucose absorption in the
gastrointestinal tract,2 and SGLT2 is responsible for glucose
reabsorption by the kidney.3
The CHMP opinion is based on evidence including
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. These three trials demonstrated that treatment with
sotagliflozin, when given to adults with inadequately controlled
T1D as an oral adjunct to insulin, resulted in consistent,
significant reductions from baseline at 24 weeks in average blood
sugar (HbA1c), body weight, systolic blood pressure and a
significant improvement of time in target blood sugar range, versus
insulin alone, at both 200-mg and 400-mg doses.4-7
The European Commission is expected to make a
final decision on the Marketing Authorization Application for
sotagliflozin in the EU in the coming months.
Sotagliflozin is also currently being reviewed
by the U.S. Food and Drug Administration (FDA) and has the
potential to be the first oral antidiabetic drug approved in the
U.S. for use together with insulin therapy to improve glycemic
control in adults living with T1D. The target FDA action date under
the Prescription Drug User Fee Act (PDUFA) is anticipated to be
March 22, 2019.8
* The EMA and FDA have conditionally accepted
Zynquista™ as the trade name for sotagliflozin.
References
- Lapuerta P, et al. Diabetes and
Vascular Disease Research. 2015;12(2):101-10, DOI:
10.1177/1479164114563304.
- Hummel CS et al. Am J Physiol Cell
Physiol 2011;300(1):C14-C21, DOI: 10.1152/ajpcell.00388.2010.
- Wright EM et al. Physiol Rev
2011;91:733–794.
- Buse JB et al, Diabetes Care 2018 Jun;
dc180343. https://doi.org/10.2337/dc18-0343.
- Danne T et al, Diabetes Care 2018 Jun;
dc180342. https://doi.org/10.2337/dc18-0342.
- Garg SK et al, N Engl J Med 2017;
377:2337-2348, DOI: 10.1056/NEJMoa1708337.
- Danne T et al. “inTandem1 and
inTandem2: increased time in range with sotagliflozin as adjunct
therapy to insulin in adults with type 1 diabetes by 24-week
continuous glucose monitoring”, Abstract #610, presented at
European Association for the Study of Diabetes 54th Annual Meeting,
October 1-5, 2018, Berlin, Germany. Available via
https://www.easd.org/virtualmeeting/home.html#!resources/intandem1-and-intandem2-increased-time-in-range-with-sotagliflozin-as-adjunct-therapy-to-insulin-in-adults-with-type-1-diabetes-by-24-week-continuous-glucose-monitoring
[Accessed February 2019].
- Sanofi press release, “FDA advisory
committee votes on Zynquista™ (sotagliflozin) as treatment for
adults with type 1 diabetes”. Available via
http://hugin.info/152918/R/2231739/877460.pdf [Accessed February
2019].
About Lexicon
Pharmaceuticals
Lexicon 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.
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
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.
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 marketing and other potential of the
product, or regarding potential future revenues from the product.
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, unexpected regulatory actions or delays, or government
regulation generally, that could affect the availability or
commercial potential of the product, the absence of guarantee that
the product will be commercially successful, the uncertainties
inherent in research and development, including future clinical
data and analysis of existing clinical data relating to the
product, including post marketing, unexpected safety, quality or
manufacturing issues, competition in general, risks associated with
intellectual property and any related future litigation and the
ultimate outcome of such litigation, 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 Investor Relations
Contact:
Kimberly Lee, D.O.Head of Investor Relations and
Corporate Strategy(281) 863-3383klee@lexpharma.com
Lexicon Media Relations
Contact:
Chas SchultzExecutive Director, Corporate
Communications and Patient Advocacy(281)
863-3421cschultz@lexpharma.com
Sanofi Investor Relations
Contact:
George Grofik+33 (0)1 53 77 45
45ir@sanofi.com
Sanofi Media Relations
Contact:
Nicolas Kressmann(732)
532-5318Nicolas.kressmann@sanofi.com
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