FDA Advisory Committee does not recommend that sotagliflozin receive approval for glucose lowering in adults with type 1 diabetes (T1D) and Chronic Kidney Disease (CKD)
Update – November 22, 2024 This morning, Lexicon Pharmaceuticals, Inc. (Lexicon) announced they received a “deficiencies preclude discussion” letter from the FDA regarding this drug application. The FDA is not approving sotagliflozin for use in glucose control in people with T1D and CKD and there will be no further discussion in regards to this application. […]
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