Breakthrough T1D, formerly JDRF, is extremely disappointed that the U.S. Food and Drug Administration (FDA) decided not to approve Zynquista (sotagliflozin), manufactured by Lexicon Pharmaceuticals, for use in glucose control in people with type 1 diabetes (T1D) and chronic kidney disease. People with T1D need additional therapies to manage this burdensome disease, and we believe the benefits of this drug outweigh the risks for this indication.
While Lexicon will no longer pursue a glucose control indication for sotagliflozin in people with T1D and chronic kidney disease, our funded research exploring the use of sotagliflozin in people with T1D and kidney or heart disease will proceed. We will continue to work on multiple fronts for therapies, like this one, that can help address the burdens and unmet needs of the T1D community and urge regulators to weigh the inherent risks of living with T1D when considering these therapies.
Read more about SGLT inhibitors and T1D here.
