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.
