FDA Rejects Sotagliflozin for Individuals with Type 1 Diabetes and Chronic Kidney Disease
By Ryanne Paul, IDS Diabetes Intern
The medication sotagliflozin (Zynquista) is a dual sodium-glucose cotransporter (SGLT) inhibitor. It lowers glucose levels in people with all forms of diabetes by facilitating the secretion of sugar in the urine, and is approved for use in people with type-1 diabetes in Europe. Recently, Zynquista was brought to the US Food and Drug Administration (FDA) to be approved to be used as an adjunct medication by people with type 1 diabetes (T1D) and chronic kidney disease (CKD).
The first time sotagliflozin was brought to the FDA for approval was in 2019. It was not approved because the risk of diabetes ketoacidosis (DKA) was a greater concern than any benefits it would provide. Almost a year later, Lexicon Pharmaceuticals appealed the FDA’s decision but was unsuccessful. The FDA still had problems with the increased DKA risk; Lexicon also lacked enough clinical data to support the benefits of the drug for individuals with T1D.
In 2022, the FDA approved Inpefa, another brand name for sotagliflozin, to reduce heart complications in adults with type-2 diabetes. After discovering that the drug was found to improve kidney function in people with diabetes and kidney disease, Lexicon resubmitted the drug for approval on the premise that the benefits greatly outweigh the risks. Again, it was not approved due to DKA concerns. This is despite the development of effective strategies for minimizing the risk of DKA in people who use it – including adequate hydration and carbohydrate intake, regular ketone monitoring, and discontinuation of the drug during illness.
Unfortunately for the T1D community, Lexicon has announced that they will stop fighting to get sotaglflozin approved. They will now focus on LX9211, a different compound that addresses diabetic peripheral neuropathic pain.
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