Lexicon Pharmaceuticals

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FDA advisory committee voted 11 to 3 against sotagliflozin's safety-benefit profile for type 1 diabetes and chronic kidney disease, casting doubt on its approval. Lexicon Pharmaceuticals remains hopeful for future approval, citing potential benefits and support from the diabetes community.

An FDA panel voted 11-3 against recommending sotagliflozin as an adjunct to insulin for type 1 diabetes patients with mild-to-moderate chronic kidney disease, citing insufficient data and risks of diabetic ketoacidosis.

FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 11 to 3 that Zynquista (sotagliflozin) benefits do not outweigh risks in adults with type 1 diabetes and chronic kidney disease. FDA is reviewing approval for Zynquista as an adjunct to insulin, with a goal date of Dec. 20, 2024. Concerns include uncertainties about benefits for patients with mild-to-moderate chronic kidney disease and risks of diabetic ketoacidosis.

FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 11-3 against Lexicon Pharmaceuticals’ sotagliflozin, citing insufficient clinical data and risks outweighing benefits. Lexicon proposed sotagliflozin as an adjunct to insulin for type 1 diabetes and chronic kidney disease patients.

FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 11 to 3 that sotagliflozin's benefits do not outweigh risks in T1D and mild-to-moderate CKD patients on insulin therapy. Lexicon awaits FDA decision by December 20, 2024, with ongoing support for sotagliflozin in specific T1D and CKD subpopulations.

Lexicon Pharmaceuticals announced the FDA EMDAC's 11-3 vote against Zynquista's approval for T1D and CKD, despite community support. The PDUFA target action date is December 20, 2024.

Lexicon Pharmaceuticals' Zynquista received a negative vote from an FDA advisory committee for use with insulin therapy in Type 1 diabetes and chronic kidney disease patients, with 11 against and 3 in favor. The company remains hopeful for future approval.

Lexicon Pharmaceuticals announced the FDA EMDAC's 11-3 vote against Zynquista's approval for T1D and CKD patients, despite community support. The FDA's PDUFA target action date is December 20, 2024.