Lexicon Voluntarily Withdraws Sotagliflozin New Drug Application and Plans Prompt Resubmission Targeted Early Q2 2022
February 28 2022 - 6:00AM
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced the
voluntary withdrawal and planned near-term resubmission of the
company’s New Drug Application (NDA) for sotagliflozin to correct a
technical issue with the submission recently identified by the
company. The company promptly notified the U.S. Food and Drug
Administration (FDA) about the issue and has been in discussions
with the agency to correct the submission. Due to the proximity to
the conclusion of the 60-day filing review period, Lexicon
determined, after consultation with the FDA, that the withdrawal of
the NDA and a subsequent resubmission would be the most appropriate
action to provide a complete submission for review.
“The NDA resubmission is our top priority,” said
Lonnel Coats, Lexicon’s chief executive officer. “We consider our
ongoing dialogue with the FDA to be encouraging and are targeting a
resubmission early in the second quarter of 2022.”
Lexicon management will hold a live conference
call and webcast today at 8:00 am ET / 7:00 am CT. The dial-in
number for the conference call is 888-645-5785 (U.S./Canada) or
970-300-1531 (international). The conference ID for all callers is
8051406. The live webcast and replay may be accessed by visiting
Lexicon’s website at www.lexpharma.com/investors. An archived
version of the webcast will be available on the website for 14
days.
About Sotagliflozin
Discovered using Lexicon’s unique approach to
gene science, sotagliflozin is an 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.
Sotagliflozin is approved in the European Union (EU) for use as an
adjunct to insulin therapy to improve blood sugar (glycemic)
control in adults with type 1 diabetes with a body mass index ≥ 27
kg/m2, who could not achieve adequate glycemic control despite
optimal insulin therapy, but has not yet been commercially
launched.
About Lexicon
Pharmaceuticals
Lexicon is a biopharmaceutical company with a
mission of pioneering medicines that transform patients’ lives.
Through its Genome5000™ program, Lexicon scientists studied the
role and function of nearly 5,000 genes and 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. Lexicon advanced
one of these medicines to market and has a pipeline of promising
drug candidates in discovery and clinical and preclinical
development in heart failure, neuropathic pain, diabetes and
metabolism and other indications. For additional information,
please visit www.lexpharma.com.
Safe Harbor Statement
This press release contains “forward-looking
statements,” including statements relating to Lexicon’s financial
position and long-term outlook on its business, including the
clinical development of, regulatory filings for, and potential
therapeutic and commercial potential of sotagliflozin, LX9211 and
its other potential drug candidates. In addition, this press
release also contains forward looking statements relating to
Lexicon’s growth and future operating results, discovery and
development 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 Lexicon’s ability to resubmit its NDA for sotagliflozin
on its anticipated timelines and gain FDA acceptance of such
resubmission. Additional important factors include Lexicon’s
ability to meet its capital requirements, successfully conduct
preclinical and clinical development and obtain necessary
regulatory approvals of sotagliflozin, LX9211 and its other
potential drug candidates on its anticipated timelines,
successfully commercialize any products for which it obtains
regulatory approval, 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, 2020, 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 Inquiries:
Chas SchultzExecutive Director, Corporate
Communications and Investor RelationsLexicon Pharmaceuticals(281)
863-3421cschultz@lexpharma.com
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