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Lexicon Aims to Resubmit New Drug Application for Type 1 Diabetes Treatment Sotagliflozin to the FDA Later This Year

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Resubmission plan comes amid feedback and a complete response letter issued by the FDA in 2019 for sotagliflozin in the treatment of glycemic control in type 1 diabetes patients with chronic kidney disease.

Woman administering a self diabetes stick test. Image Credit: Adobe Stock Images/Michael O'Neill

Image Credit: Adobe Stock Images/Michael O'Neill

Lexicon Pharmaceuticals announced its intentions to resubmit a New Drug Application (NDA) to the FDA seeking approval for sotagliflozin to improve glycemic control in type 1 diabetes patients with chronic kidney disease (CKD). According to the company, the NDA resubmission is planned for mid-2024, with hopes for regulatory approval within six months. It comes amid previous challenges, including a complete response letter (CRL) that the FDA issued in 2019. In 2021, the two parties agreed to a public Notice of Opportunity for Hearing (NOOH) to debate whether a complete denial was ethical and to discuss a path forward.1

“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, CEO, Lexicon Pharmaceuticals, in a press release. “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.”

Lexicon also revealed positive results from its post hoc analysis of the inTandem3 Phase III trial, which found that sotagliflozin shows promise in glycemic control among type 1 diabetes patients with CKD. The analysis, which was presented at the 17th International Conference on Advanced Technologies and Treatments for Diabetes, relied on data from a 24-week multinational, placebo-controlled trial. Further, results found that sotagliflozin plus insulin therapy effectively lowered A1C levels, body weight, and systolic blood pressure without increasing the risk of severe hypoglycemia or diabetic ketoacidosis compared to a placebo in a subset of 228 patients out of a total of 1402 patients enrolled in the trial.2

“Our research team concluded that in patients with type 1 diabetes and CKD, treatment with sotagliflozin had similar A1C, body weight and systolic blood pressure lowering effects as compared to its effect on the total cohort” said abstract contributing author David Z.I. Cherney, MD, PhD, professor in the Department of Medicine at the University of Toronto, in a press release.

According to the CDC, one-third of adults with diabetes also struggle with CKD, while both types 1 and type 2 have the potential to cause CKD.3

“Each kidney is made up of millions of tiny filters called nephrons. Over time, high blood sugar from diabetes can damage blood vessels in the kidneys as well as nephrons so they don’t work as well as they should. Many people with diabetes also develop high blood pressure, which can damage kidneys too,” says the CDC. “CKD takes a long time to develop and usually doesn’t have any signs or symptoms in the early stages. You won’t know you have CKD unless your doctor checks you for it.”

Lexicon officials noted that the promising findings from the nTandem3 trial support the use of sotagliflozin in this patient population.

“This research adds important data to the body of evidence supporting our plans to resubmit our New Drug Application for sotagliflozin as an adjunct to insulin therapy in people with type 1 diabetes and CKD,” said Craig Granowitz, MD, PhD, SVP, chief medical officer, Lexicon, in the press release. “We are optimistic that sotagliflozin may become an important new treatment option for this important population.”

References

1. Lexicon Preparing to Resubmit Sotagliflozin NDA for Type 1 Diabetes Following Feedback From FDA. Lexicon. March 11, 2024. Accessed March 13, 2024. https://www.lexpharma.com/media-center/news/2024-03-11-lexicon-preparing-to-resubmit-sotagliflozin-nda-for-type-1-diabetes-following-feedback-from-fda

2. New Post Hoc Analysis of inTandem3 Study Demonstrates Improvements in Glycemic Control With Sotagliflozin Treatment in Patients With Type 1 Diabetes and Chronic Kidney Disease. Lexicon. March 12, 2024. Accessed March 13, 2024. https://www.lexpharma.com/media-center/news/2024-03-12-new-post-hoc-analysis-of-intandem3-study-demonstrates-improvements-in-glycemic-control-with-sotagliflozin-treatment-in-patients-with-type-1-diabetes-and-chronic-kidney-disease

3. Diabetes and Chronic Kidney Disease. CDC. Accessed March 13, 2024. https://www.cdc.gov/diabetes/managing/diabetes-kidney-disease.html#:~:text=Approximately%201%20in%203%20adults,diabetes%20can%20cause%20kidney%20disease.

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