Lexicon Pharmaceuticals on Track to Resubmit Sotagliflozin for Type 1 Diabetes Approval

Ever since facing its initial setback with the FDA half a decade ago, Lexicon Pharmaceuticals has persisted in its quest for approval of sotagliflozin, a prospective treatment for Type 1 diabetes. Recent regulatory insights have reignited the company’s aspirations, prompting plans for a resubmission of its application by mid-year.
CEO Lonnel Coats emphasized Lexicon’s dedication to advancing sotagliflozin as a potential breakthrough therapy for Type 1 diabetes. The company aims for approval allowing sotagliflozin to complement insulin therapy in adults with Type 1 diabetes mellitus and chronic kidney disease, under the proposed brand name Zynquista.
Lexicon’s journey encountered its initial obstacle in 2019 when the FDA rejected its application, citing safety concerns highlighted in a comprehensive response letter.

While the FDA’s decision initially hampered progress in the United States, Zynquista secured approval in Europe in 2019, offering a glimmer of validation for Lexicon’s endeavors. The company boasts a wealth of phase 3 data affirming Zynquista’s efficacy in managing diabetes with chronic kidney disease when used alongside insulin.
For Lexicon, securing approval for sotagliflozin would mark a significant milestone, potentially bolstering its financial standing. Despite reporting $1.2 million in total revenues for 2023, the company faced net losses amounting to $175.6 million for the same period, underscoring the potential role sotagliflozin might play in its future trajectory.
Amidst its pursuit of FDA approval for sotagliflozin in Type 1 diabetes, Lexicon has also explored alternative indications for the drug. Notably, it garnered approval for treating heart failure, marketed as Inpefa, in 2023, signaling a diversification of its therapeutic portfolio. Additionally, ongoing investigations into sotagliflozin’s potential applications in hypertrophic cardiomyopathy further underscore its versatility.

Recent findings from the inTandem3 Phase 3 trial presented at the ATTD 2024 conference shed light on sotagliflozin’s efficacy in enhancing glycemic control in patients with Type 1 diabetes and chronic kidney disease. The analysis revealed promising outcomes, including improvements in A1C levels, body weight, and systolic blood pressure, aligning with Lexicon’s ambitions for the drug’s regulatory approval.
Dr. David Z.I. Cherney, a prominent figure in the field, emphasized the significance of these findings, further bolstering Lexicon’s rationale for resubmitting its New Drug Application for sotagliflozin. Dr. Craig Granowitz, Lexicon’s senior vice president and chief medical officer, echoed this sentiment, expressing optimism regarding sotagliflozin’s potential as a pivotal treatment option for this patient population.