The Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA). voted eight to eight on the question of whether the overall benefits of Zynquista (sotagliflozin) outweighed the risks to support approval. Sotagliflozin is an investigational oral dual SGLT1 and SGLT2 inhibitor under regulatory review as an adjunct to insulin for the treatment of adults with type 1 diabetes (T1D).

While the FDA is not required to follow the committee™s vote, the agency considers the committee™s recommendations when making its decision, which is anticipated by March 22, 2019. Sotagliflozin, developed by Sanofi and Lexicon, has the potential to be the first oral antidiabetic drug approved in the United States together with insulin therapy to improve glycemic (blood sugar) control in adults with T1D. Sotagliflozin is an investigational oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-dependent glucose co-transporter types 1 and 2 (SGLT1 and SGLT2).

SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidney. In clinical trials, when used in combination with insulin therapy, sotagliflozin significantly improve glycemic control without increasing hypoglycemia,” said Pablo Lapuerta. results could not be achieved with insulin alone.

Diabetic ketoacidosis is an inherent risk of type 1 diabetes and an increase was seen with sotagliflozin compared to insulin alone.