It was reported yesterday that the US Food and Drug Administration (FDA) has accepted France-based Sanofi's regulatory filing for Zynquista (sotagliflozin).

The investigational oral treatment is to be used in addition to insulin therapy to improve blood sugar control in adults with type 1 diabetes.

The product has been developed in collaboration with Lexicon Pharmaceuticals Inc. It is an investigational oral dual inhibitor of SGLT-1 and SGLT-2, proteins that influence how the intestines and kidneys absorb and eliminate sugar (glucose) resulting in improved glucose control and additional clinical benefits. The FDA New Drug Application for sotagliflozin is based on data from the inTandem clinical trial program, which includes three Phase three clinical trials evaluating the safety and efficacy of Zynquista in around 3,000 adults with inadequately controlled type one diabetes. The safety and efficacy data have not yet been evaluated by any regulatory authority.

A regulatory application was also submitted by Sanofi to the European Medicines Agency earlier this year.