FDA Drugs Advisory Committee rejects Zynquista (sotagliflozin) as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease.-Lexicon Pharma

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) >45 to <60 mL/min.1.73 m² or eGFR >60 mL/min/1.73 m² and urine albumin-to-creatinine ratio (uACR) > 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.”

“Insulin is essential to managing this disease, but it is not sufficient in keeping patients within appropriate blood glucose ranges,” said Steve Edelman, MD, a professor of medicine in the Division of Endocrinology, Diabetes & Metabolism at the University of California, San Diego (UCSD), and founder and director of Taking Control Of Your Diabetes (TCOYD). “Only 20 percent of people with T1D currently achieve adequate glycemic control with insulin alone. Zynquista, if approved, would be the first oral medication for people with T1D, with potential to impact renal and cardiovascular outcomes, especially in those with CKD who face even greater disease progression risks.”