Lexicon Preparing to Resubmit Sotagliflozin NDA for Type 1 Diabetes Following Feedback From FDA
Preparations Underway for Resubmission of New Drug Application for Sotagliflozin as an Adjunct to Insulin Therapy for Glycemic Control in Patients with Type 1 Diabetes and Chronic Kidney Disease
Resubmission is Anticipated Mid-2024
THE WOODLANDS, Texas, March 11, 2024 (GLOBE NEWSWIRE) -- 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 DeFrancesco
Lexicon Pharmaceuticals, Inc.
lexinvest@lexpharma.com
For Media Inquiries:
Alina Cocuzza
Lexicon Pharmaceuticals, Inc.
acocuzza@lexpharma.com
