Lexicon’s Sotagliflozin Returns To US FDA Panel With Narrowed Indication

 
• By Sue Sutter

The Zynquista application in type 1 diabetes received a complete response letter in 2019. This time, Lexicon seeks approval for patients with T1D and chronic kidney disease. FDA review staff said making definitive conclusions about the magnitude of glucose-lowering effects in this population is difficult, and the risk of diabetic ketoacidosis remains.

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Sotagliflozin for type 1 diabetes is returning to the Endocrinologic and Metabolic Drugs Advisory Committee, which rendered a split decision in 2019. (Shutterstock)

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