Lexicon Pharmaceuticals Inc. (LXRX) has reported that the U.S. Food and Drug Administration's (FDA) Advisory Committee has voted against approving the company's New Drug Application (NDA) for Zynquista (sotagliflozin). This oral SGLT1/SGLT2 inhibitor is intended as a supplementary treatment to insulin for managing blood sugar levels in adults with type 1 diabetes and chronic kidney disease. The Endocrinologic and Metabolic Drugs Advisory Committee reached a decision with an 11 to 3 vote, indicating that they felt the potential risks of Zynquista outweigh its potential benefits for this particular patient group.
Despite the overall decision, some members of the committee voiced their support for sotagliflozin in certain sub-populations of individuals with type 1 diabetes and chronic kidney disease. They suggested that for these specific groups, the benefits might exceed the associated risks, according to statements from the company.
The Advisory Committee's vote is not mandatory for the FDA but is generally taken into account during the FDA's decision-making process. The FDA has set a target date of December 20, 2024, under the Prescription Drug User Fee Act (PDUFA) for making a final decision.
