Diabetes Endpoints: A1C Reduction Is ‘Still Enough,’ Just Not For Lexicon’s Sotagliflozin, US FDA Says

 
• By Sue Sutter

The agency reaffirmed support for a hemoglobin A1C endpoint for glycemic control in type 1 diabetes, but the diabetic ketoacidosis risk with sotagliflozin is so concerning that it is looking for additional benefits in patients with chronic kidney disease, a targeted subpopulation.

Is the FDA moving the regulatory goalposts for sotagliflozin by searching for benefits beyond reduction in hemoglobin A1C? (Shutterstock)

More from US Advisory Committees

More from Pathways & Standards