ZynquistaTM now approved
in the European Union for treatment of adults with type 1
diabetes
PARIS and THE WOODLANDS, TX - April 26, 2019 -
The European Commission has granted marketing authorization for
Zynquista(TM)
(sotagliflozin)*, developed by Sanofi and Lexicon. Zynquista is now
approved in the European Union, at once-daily doses of 200 mg and
400 mg, for use as an adjunct to insulin therapy to improve blood
sugar (glycemic) control in adults with type 1 diabetes (T1D)
mellitus and a body mass index >= 27 kg/m2, who
could not achieve adequate glycemic control despite optimal insulin
therapy.
"Millions of people across Europe who live with
type 1 diabetes struggle to control their blood sugar, even with
optimal insulin therapy," commented Thomas Danne, Professor of
Pediatrics, Children's Hospital 'Auf der Bult,' Hannover, Germany.
"For the many people living with type 1 diabetes
who are overweight or obese, Zynquista will offer a new treatment
option physicians can now consider in combination with insulin
therapy for appropriate patients."
Zynquista is an 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
"Zynquista's dual mechanism of action provides
important treatment benefits for adults with type 1 diabetes,
including reducing blood sugar reabsorption in the kidneys through
SGLT2 inhibition and delaying dietary sugar absorption through
local SGLT1 inhibition in the intestinal tract," added John
Reed, M.D., Ph.D., Global Head of Research & Development,
Sanofi.
The marketing authorization 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, involving approximately 3,000 adults with
inadequately controlled T1D.4-7
"We are proud to have developed Zynquista in
combination with insulin through the largest Phase 3 clinical trial
program to date in adults with type 1 diabetes, and now to have it
approved in the European Union," said Pablo Lapuerta, M.D.,
Executive Vice President and Chief Medical Officer, Lexicon.
"We thank the European Commission for recognizing
the clinical benefits of Zynquista for adults with type 1 diabetes
and the families and physicians who participated in the clinical
trials."
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 and significant
reductions from baseline at 24 weeks in average blood sugar
(HbA1c), body
weight, systolic blood pressure, a significant improvement of time
in target blood sugar range and improved patient-reported outcomes,
versus insulin alone, at both 200-mg and 400-mg doses.4-7 This was
achieved without the usual increase in severe hypoglycemia that
comes with intensification of insulin and with less events of
severe hypoglycemia in the 400-mg dose at 52 weeks.
Consistent with selective SGLT2 inhibitors, clinical trials with
sotagliflozin showed an increased risk of genital mycotic
infections and diabetic ketoacidosis (DKA), which is acknowledged
to affect people with T1D more frequently than those with type 2
diabetes (T2D). Several leaders in the diabetes scientific
community consider the risk of DKA associated with SGLT inhibitors
manageable with appropriate patient selection, education and ketone
monitoring in place.8-11 The risk
of DKA will be addressed by careful selection of patients for
treatment with sotagliflozin and through a risk-management plan and
a mitigation strategy, including patient, healthcare professional
and care giver educational activities, that will support its safe
use.
Zynquista is also currently being evaluated in a program of 11
clinical trials in adults with T2D, including two trials in people
living with T2D and renal impairment, and two large cardiovascular
outcomes trials.
*Zynquista(TM) (sotagliflozin) is not currently approved for use in
any other markets, where it is considered an investigational
product.
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 April 2019].
-
Peters AL et al. Diabetes Care 2015
Jun; dc150843.https://doi.org/10.2337/dc15-0843
-
Rosenstock J, Ferrannini E. Diabetes
Care 2015
Sep; 38(9): 1638-1642.https://doi.org/10.2337/dc15-1380
-
Garber AJ et al. Endocrine Practice: January
2019, Vol. 25, No. 1, pp.
69-100.https://doi.org/10.4158/CS-2018-0535
-
Danne T et al. Diabetes Care 2019
Feb; dc182316.https://doi.org/10.2337/dc18-2316
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
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Sanofi Media Relations Contact Nicolas
Kressmann
Tel: +1 (732) 532-5318
nicolas.kressmann@sanofi.com
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Sanofi Investor Relations Contact George
Grofik
Tel: +33 (0)1 53 77 45 45
ir@sanofi.com
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Lexicon Media Relations
Contact Chas Schultz
Tel: 281-863-3421
cschultz@lexpharma.com
|
Lexicon Investor Relations
Contact Kimberly Lee, D.O.
Tel: 281-863-3383
klee@lexpharma.com
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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
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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, 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, 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. |