FDA Advisory Committee to Review Investigational Sotagliflozin as Potential Treatment for Type 1 Diabetes
November 29 2018 - 9:00AM
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that
the U.S. Food and Drug Administration (FDA) Endocrinologic and
Metabolic Drugs Advisory Committee (EMDAC) plans to review Lexicon
collaborator Sanofi’s New Drug Application (NDA) for sotagliflozin,
an investigational oral treatment for adults with type 1 diabetes,
on January 17, 2019.
The FDA accepted the NDA for sotagliflozin on
May 22, 2018. The NDA included data from the inTandem clinical
trial program, which includes three Phase 3 clinical trials
assessing the safety and efficacy of sotagliflozin in approximately
3,000 adults with inadequately controlled type 1 diabetes.
The target date for an FDA action regarding
sotagliflozin under the Prescription Drug User Fee Act (PDUFA) is
anticipated to be March 22, 2019.
About Sotagliflozin
Discovered using Lexicon’s unique approach to
gene science, sotagliflozin is an investigational oral dual
inhibitor of two proteins responsible for glucose regulation known
as sodium-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.
Lexicon entered into a collaboration and license
agreement with Sanofi in November 2015 under which Lexicon granted
Sanofi an exclusive, worldwide (excluding Japan), royalty-bearing
right and license to develop, manufacture and commercialize
sotagliflozin. Lexicon is responsible for all clinical development
activities relating to type 1 diabetes and has exercised an
exclusive option to co-promote and have a significant role, in
collaboration with Sanofi, in the commercialization of
sotagliflozin for the treatment of type 1 diabetes. In the U.S.,
Sanofi is responsible for all clinical development and
commercialization of sotagliflozin for the treatment of type 2
diabetes worldwide (excluding Japan) and is solely responsible for
the commercialization of sotagliflozin for the treatment of type 1
diabetes outside the U.S. (excluding Japan). A New Drug Application
(NDA) and a Marketing Authorization Application (MAA) for
sotagliflozin are currently under review at the U.S. Food and Drug
Administration and the European Medicines Agency (EMA),
respectively, and the product has not yet been approved for use in
the U.S. or in Europe.
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.
Safe Harbor Statement
This press release contains “forward-looking
statements,” including statements relating to Lexicon’s and
Sanofi’s clinical development of and regulatory filings for
sotagliflozin and the potential therapeutic and commercial
potential of sotagliflozin. 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 sotagliflozin 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 sotagliflozin. As a
result, sotagliflozin 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.
For Investor Inquiries:
Kimberly Lee, D.O.Head of Investor Relations and
Corporate StrategyLexicon Pharmaceuticals(281)
863-3383klee@lexpharma.com
For Media Inquiries:
Chas SchultzExecutive Director, Corporate
Communications and Patient AdvocacyLexicon Pharmaceuticals(281)
863-3421cschultz@lexpharma.com
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