Sotagliflozin accepted by EMA for review in treating people with type 1 diabetes

The European Medicines Agency (EMA) has accepted the diabetes drug sotagliflozin for review as a treatment for adults with type 1 diabetes.
Sotagliflozi, developed by Sanofi and Lexicon Pharmaceuticals, is an investigational dual SGLT1 and SGLT2 inhibitor designed to be used in combination with insulin to improve blood glucose control.
SGLT1 proteins are responsible for glucose absorption in the gastrointestinal tract whereas SGLT2 is responsible for glucose reabsorption by the kidney. The drug therefore affects how the intestines and kidneys process glucose, helping to lower sugar levels.
Lexicon and Sanofi submitted the drug this week to the EMA based on data from the inTandem clinical trials program, where sotagliflozin was assessed in around 3,000 adults with poorly controlled type 1 diabetes.
Findings from the study include improved HbA1c levels and lower rates of severe hypoglycemia. However, the drug was also associated with higher rates of diabetic ketoacidosis (DKA). The EMA will now fully review the safety and efficacy of the drug.
Sotagliflozin is the first investigative dual SGLT1/2 inhibitor to be accepted for regulatory review in Europen, and if approved by the EMA could help people with poorly controlled type 1 diabetes to achieve better glycemic control.
Thomas Danne, M.D., Head of the Diabetes Center at the Children’s Hospital on the Bult in Hannover, Germany and lead investigator for the inTandem2 clinical trial, said: “Sotagliflozin has a unique mode of action that, if approved, would offer adults suffering from type 1 diabetes and healthcare professionals improved glycemic management on top of insulin alone.”
“We and our collaborator, Sanofi, plan to work closely with the EMA and Committee for Medicinal Products for Human Use (CHMP) toward the goal of bringing sotagliflozin to people living with type 1 diabetes in Europe as quickly as possible,” added Pablo Lapuerta, M.D., executive vice president and chief medical officer at Lexicon.