Lexicon Preparing to Resubmit Sotagliflozin NDA for Type 1 Diabetes Following Feedback From FDA
March 11 2024 - 7:00AM
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that,
following the receipt of recent feedback from FDA, it is preparing
to resubmit its New Drug Application (NDA) for sotagliflozin as an
adjunct to insulin therapy for glycemic control in patients with
type 1 diabetes and chronic kidney disease (CKD). The resubmission
is planned for mid-year, with an anticipated six-month regulatory
review period.
“We have remained steadfast in our support of
sotagliflozin in type 1 diabetes and have worked diligently to
identify a regulatory path forward for what we believe will be an
important new therapy,” said Lonnel Coats, Director and Chief
Executive Officer. “We will now focus those efforts on resubmitting
our NDA by mid-year and seeking regulatory approval as early as
possible for the many people with type 1 diabetes who have
CKD.”
FDA issued a complete response letter (CRL)
regarding the NDA for sotagliflozin for type 1 diabetes in 2019
and, at Lexicon’s request, issued a public Notice of Opportunity
for Hearing (NOOH) in 2021 on whether there were grounds for
denying such approval. Lexicon and FDA subsequently agreed in late
2023 to hold the NOOH proceedings in abeyance in order to engage in
discussions regarding a path forward for resubmission and potential
approval of the NDA.
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 treat diseases safely and effectively. Lexicon has
advanced multiple medicines to market and has a pipeline of
promising drug candidates in heart failure, neuropathic pain,
diabetes and metabolism and other indications.
Safe Harbor Statement
This press release contains “forward-looking
statements,” including statements relating to the therapeutic and
commercial potential, research and clinical development and
regulatory status of sotagliflozin in type 1 diabetes. In addition,
this press release may also contain forward looking statements
relating to Lexicon’s financial position and long-term outlook on
its business, 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 meet its capital requirements,
successfully commercialize INPEFA® (sotagliflozin) in heart failure
on the timeline and/or at the prices currently contemplated or at
all, conduct preclinical and clinical development and obtain
necessary regulatory approvals of sotagliflozin in type 1 diabetes
and other indications, LX9211 and its other 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, 2022 and other
subsequent disclosure documents 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:Lisa
DeFrancescoLexicon Pharmaceuticals, Inc.lexinvest@lexpharma.com
For Media Inquiries:Alina
CocuzzaLexicon Pharmaceuticals, Inc.acocuzza@lexpharma.com
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