FDA Advisory Committee Rejects Lexicon’s Zynquista for Type 1 Diabetes and Chronic Kidney Disease

FDA Advisory Committee Vote:
The Endocrinologic and Metabolic Drugs Advisory Committee voted 11 to 3 against Zynquista (sotagliflozin) for use in adults with type 1 diabetes and chronic kidney disease, citing that the risks do not outweigh the benefits.

Previous Rejection:
In 2019, the FDA rejected Zynquista for the same indication, and the drug was later approved for heart failure treatment under the name Inpefa.

European Approval:
The European Medicines Agency (EMA) has approved Zynquista as an adjunct to insulin for patients with type 1 diabetes and chronic kidney disease.

Potential Benefits:
Some committee members suggested that Zynquista might have benefits for specific subpopulations of patients with type 1 diabetes and chronic kidney disease, particularly those with mild to moderate kidney impairment, but emphasized the need for additional data.

FDA Review:
The FDA is currently reviewing the approval of Zynquista, with a Prescription Drug User Fee Act (PDUFA) target action date of December 20, 2024.

Stock Impact:
Following the negative vote, Lexicon's stock plummeted by 38.7% at the start of trading on November 1.