Sanofi : CHMP recommends ZynquistaTM (sotagliflozin) for the treatment of adults with type 1 diabetes
01 Marzo 2019 - 7:01AM
CHMP recommends ZynquistaTM (sotagliflozin)
for the treatment of adults with type 1 diabetes
PARIS and THE WOODLANDS, TX - March 1,
2019 - The European Medicines Agency's Committee for Medicinal
Products for Human Use (CHMP) has adopted a positive opinion on the
Marketing Authorization of ZynquistaTM* (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 >= 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(TM) 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(TM) (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 (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.
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 ContactNicolas Kressmann Tel.:
732-532-5318 nicolas.kressmann@sanofi.comLexicon Media Relations
ContactChas Schultz Tel.: 281-863-3421cschultz@lexpharma.com
|
Sanofi Investor
Relations ContactGeorge Grofik Tel.: +33 (0)1 53 77 45 45
ir@sanofi.comLexicon Investor Relations ContactKimberly Lee,
D.O. Tel.: 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 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 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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