Lexicon Pharmaceuticals Resubmits Sotagliflozin NDA for Type 1 Diabetes
21 June 2024 - 10:00PM
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that,
following multiple interactions with and recent feedback from the
U.S. Food and Drug Administration (FDA), it has resubmitted its New
Drug Application (NDA) for sotagliflozin as an adjunct to insulin
therapy for glycemic control in people with type 1 diabetes and
chronic kidney disease (CKD).
“We are confident in the benefit/risk profile of
sotagliflozin for people with type 1 diabetes and CKD, and our team
has been resolute in identifying and pursuing a regulatory path
forward,” said Lonnel Coats, director and chief executive officer.
“We are now one step closer to bringing this important potential
therapy to market for the many people who suffer from type 1
diabetes and CKD, and who could benefit from an adjunct to insulin
therapy for glycemic control.”
In 2019, the FDA issued a complete response
letter (CRL) regarding the NDA for sotagliflozin for type 1
diabetes. In 2021, at Lexicon’s request, the FDA issued a public
Notice of Opportunity for Hearing (NOOH) 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. The application
remains in “filed” status at the FDA and the company expects to
receive a formal communication from FDA within 30 days of today’s
submission establishing the action date and anticipates a six-month
regulatory review period.
About Lexicon Pharmaceuticals
Lexicon is a biopharmaceutical company with a mission of
pioneering medicines that transform patients’ lives. Through the
Genome5000™ program, Lexicon’s unique genomics target discovery
platform, 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 disease safely and effectively. Lexicon has commercially
launched one of these medicines, INPEFA® (sotagliflozin) in the
United States, and has a pipeline of other promising drug
candidates in discovery and clinical and preclinical development in
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 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, conduct preclinical and clinical development and obtain
necessary regulatory approvals of sotagliflozin in type 1 diabetes
and other indications, LX9211, LX9851 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, 2023, 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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