Lexicon Preparing to Resubmit Sotagliflozin NDA for Type 1 Diabetes Following Feedback From FDA
Lexicon Pharmaceuticals, Inc. is preparing to resubmit its New Drug Application for sotagliflozin as an adjunct to insulin therapy for type 1 diabetes and chronic kidney disease, with an anticipated six-month regulatory review period.
From a medical research perspective, the progress towards the resubmission of the New Drug Application (NDA) for sotagliflozin is significant. Sotagliflozin, being investigated as an adjunct therapy for glycemic control in patients with type 1 diabetes and chronic kidney disease (CKD), could address a substantial unmet medical need. CKD is a prevalent complication in type 1 diabetes and managing blood sugar levels in this subgroup can be particularly challenging.
Current treatment options are limited and the introduction of sotagliflozin may offer a novel mechanism of action, as it is an SGLT2 inhibitor with additional SGLT1 inhibition properties. This dual inhibition allows it to not only improve glycemic control but potentially offer renal protective benefits, which is critical for patients with CKD. The focus on this specific patient population could lead to improved clinical outcomes and quality of life for patients, while potentially reducing healthcare costs associated with diabetes-related kidney complications.
Analyzing the financial implications, the resubmission of the NDA for sotagliflozin represents a pivotal moment for Lexicon Pharmaceuticals. The market opportunity in the type 1 diabetes segment, particularly among those with CKD, is considerable. Approval and successful commercialization could lead to a significant revenue stream for Lexicon, given the chronic nature of diabetes and the necessity for ongoing treatment.
Investors should note the history of the drug's regulatory journey, including the initial complete response letter (CRL) and the subsequent Notice of Opportunity for Hearing (NOOH). These events suggest a challenging path to approval, which has likely been factored into the company's valuation. However, the agreement to hold NOOH proceedings in abeyance and engage in discussions indicates a potential positive shift in regulatory stance. If approved, the stock could see substantial appreciation, reflecting the drug's market potential. However, the inherent risks of the drug approval process should be carefully weighed.
From a market research standpoint, the resubmission of the NDA for sotagliflozin by Lexicon Pharmaceuticals is a strategic move to capture a niche yet growing segment of the diabetes market. Type 1 diabetes affects a smaller population compared to type 2, but the addition of CKD increases the complexity and necessity for specialized treatment options.
The competitive landscape for diabetes treatments is robust, with several large pharmaceutical companies dominating the market. However, the focus on type 1 diabetes with CKD could provide Lexicon with a competitive edge, as there are fewer treatments specifically approved for this indication. Market acceptance will depend on the drug's efficacy, safety profile and pricing strategy. Additionally, payor acceptance and reimbursement levels will be critical factors in determining the drug's commercial success. Stakeholders should monitor competitor developments and potential market entry barriers that could influence sotagliflozin's performance post-approval.
03/11/2024 - 07:00 AM
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.
“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 :lexinvest@lexpharma.com
For Media Inquiries :acocuzza@lexpharma.com
Lexicon Pharmaceuticals, Inc. is planning to resubmit its New Drug Application for sotagliflozin by mid-2024.
The purpose of resubmitting the New Drug Application for sotagliflozin is as an adjunct to insulin therapy for glycemic control in patients with type 1 diabetes and chronic kidney disease.
Lexicon Pharmaceuticals, Inc. received recent feedback from the FDA regarding the New Drug Application for sotagliflozin.
An anticipated six-month regulatory review period is expected for the resubmission of the New Drug Application for sotagliflozin.
Lonnel Coats is the Director and Chief Executive Officer of Lexicon Pharmaceuticals, Inc.
