FDA Panel Votes Against Lexicon's NDA For Zynquista In Type 1 Diabetes And Chronic Kidney Disease

Lexicon Pharmaceuticals

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(RTTNews) - Lexicon Pharmaceuticals Inc. (LXRX) announced that the U.S. Food and Drug Administration's Advisory Committee voted against the company's New Drug Application (NDA) for Zynquista (sotagliflozin), an oral SGLT1/SGLT2 inhibitor, intended as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease. The Endocrinologic and Metabolic Drugs Advisory Committee voted 11 to 3, stating that the risks of Zynquista do not outweigh its benefits in this population.

During the discussion, some committee members expressed support for sotagliflozin in specific sub-populations of people with type 1 diabetes and chronic kidney disease, where they believed the benefits might outweigh the risks, the company said.

Advisory Committee votes, while not binding, are considered by the FDA in its decision-making process. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of December 20, 2024.

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