FDA panel votes 11-3 that Lexicon’s Zynquista benefits do not outweigh risks

Lexicon (LXRX) Pharmaceuticals announced the outcome of the U.S. Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee Meeting to review the company’s New Drug Application for Zynquista, an oral SGLT1/SGLT2 inhibitor, as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease. The Advisory Committee voted 11 to 3 that the benefits of Zynquista do not outweigh the risks in adults with T1D and CKD, as defined in the voting question as having estimated glomerular filtration rate (eGFR) greater than45 to less than60 mL/min.1.73 m2 or eGFR greater than60 mL/min/1.73 m2 and urine albumin-to-creatinine ratio (uACR) greater than 30mg/g. As part of the discussion, certain committee members expressed support for sotagliflozin in alternative sub-populations of people with T1D and CKD, where they believed the benefits potentially outweigh the risks. “We are disappointed in the outcome of today’s Advisory Committee vote. However, we were encouraged by the rich discussion and outpouring of support across the diabetes community in favor of sotagliflozin being made available to appropriate people with T1D and CKD,” said Dr. Mike Exton, chief executive officer and director of Lexicon Pharmaceuticals. “It’s clear from today’s discussion that an FDA-approved treatment and clear education on managing risk is urgently needed, and we believe our data supports this need. We look forward to working with the FDA as it completes its review of our NDA, and if approved, making Zynquista available to patients who could benefit from this therapy.” Advisory Committee votes, while not binding, are considered by the FDA when making its decision regarding the potential approval of a regulatory application. As previously reported, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 20, 2024.