Lexicon Pharmaceuticals Receives December 20, 2024 PDUFA Goal Date for Sotagliflozin Type 1 Diabetes NDA Resubmission
16 Luglio 2024 - 2:00PM
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that
the U.S. Food and Drug Administration (FDA) has acknowledged the
resubmission of its New Drug Application (NDA) for Zynquista™
(sotagliflozin) as an adjunct to insulin therapy for glycemic
control in adults with type 1 diabetes and chronic kidney disease
(CKD). The FDA indicated that it considers the resubmission to be a
complete response to the FDA’s 2019 action letter regarding the
sotagliflozin NDA for type 1 diabetes, providing a Prescription
Drug User Fee Act (PDUFA) goal date of December 20, 2024.
“Lexicon has continued confidence in the
favorable benefit/risk profile of sotagliflozin for adults with
type 1 diabetes and CKD. With a PDUFA date now in hand, we can
begin the next phase of launch preparation for Zynquista,” said Dr.
Mike Exton, chief executive officer and director. “If approved,
this will mark Lexicon’s second NDA approval and commercial launch
in two years of products that originated from our novel discovery
platform and advanced to regulatory approval and commercialization.
With an exciting and diverse portfolio of assets, Lexicon is
well-positioned for strong future value creation for all
stakeholders.”
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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