FDA advisory committee voted 8:8 on the overall benefits of Zynquista to treat type 1 diabetes. Sanofi + Lexicon

The Endocrinologic and Metabolic Drugs Advisory Committee of the 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. About 1.3 million Americans have T1D and an estimated 40,000 people will be newly diagnosed each year in the U.S., according to the American Diabetes Association.

Comment: The advisory committee was concerned for a diabetic ketoacidosis (DKA) risk, which was higher among patients on sotagliflozin during its clinical trials. Diabetic ketoacidosis can lead to coma, encephalopathy, respiratory failure, acute kidney injury and death.