Testimony Before the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee Regarding Sotagliflozin
In testimony before the Food and Drug Administration’s (FDA’s) Endocrinologic and Metabolic Drugs Advisory Committee, Public Citizen urged the committee to recommend that the FDA not approve sotagliflozin as an adjunct to insulin therapy to improve glycemic control in adults with type 1 diabetes mellitus and chronic kidney disease because there is a lack of substantial evidence demonstrating the effectiveness and safety of sotagliflozin in this population.