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Lexicon's Sotagliflozin Faces FDA Panel Again with Narrowed Indication for Type 1 Diabetes and Chronic Kidney Disease

• Lexicon Pharmaceuticals is seeking FDA approval for sotagliflozin, targeting type 1 diabetes patients with chronic kidney disease. • The FDA review staff has expressed concerns about accurately assessing glucose-lowering effects in this specific patient population. • A key concern remains the potential risk of diabetic ketoacidosis associated with sotagliflozin use in type 1 diabetes patients. • This marks sotagliflozin's return to the Endocrinologic and Metabolic Drugs Advisory Committee after a prior split decision in 2019.

Lexicon Pharmaceuticals is once again seeking FDA approval for sotagliflozin, this time with a narrowed indication focusing on patients with type 1 diabetes (T1D) and chronic kidney disease (CKD). The Endocrinologic and Metabolic Drugs Advisory Committee will review the application, revisiting a drug that received a complete response letter in 2019 for its initial application in type 1 diabetes.
The FDA review staff has raised concerns regarding the efficacy and safety profile of sotagliflozin in this specific subpopulation. According to the review, making definitive conclusions about the magnitude of glucose-lowering effects in T1D patients with CKD is difficult. This uncertainty complicates the risk-benefit assessment for this patient group.
A significant concern highlighted by the FDA is the persistent risk of diabetic ketoacidosis (DKA) associated with sotagliflozin use in individuals with type 1 diabetes. DKA is a serious and potentially life-threatening complication, and its potential exacerbation by sotagliflozin necessitates careful consideration.
This marks the second time sotagliflozin will be reviewed by the Endocrinologic and Metabolic Drugs Advisory Committee. The committee previously rendered a split decision in 2019 regarding the drug's approval for type 1 diabetes, indicating existing divisions regarding its risk-benefit profile.
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Reference News

[1]
Lexicon's Sotagliflozin Returns To US FDA Panel With Narrowed Indication
pink.pharmaintelligence.informa.com · Oct 29, 2024

Lexicon’s sotagliflozin returns to FDA for approval in type 1 diabetes and chronic kidney disease patients, after a 2019...

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