The FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 11 to 3 against recommending the SGLT1/SLGT2 inhibitor to treat adults with T1D and CKD.
In a post hoc analysis of the SCORED trial, investigators observed positive renal protection with sotagliflozin across a spectrum of baseline kidney function and glycemic control.
Lexicon's sotagliflozin is on the October 31 docket for discussion by the FDA's Endocrinologic and Metabolic Drugs Advisory Committee; PDUFA goal date remains set for December 20.
ADA 2024. Semaglutide benefits were observed for adults with type 2 diabetes and chronic kidney disease whether or not they used SGLT-2 inhibitors, according to an analysis of FLOW trial data.