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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)
Key Takeaways
  • Endocrinologic and Metabolic Drugs Advisory Committee patient representative Paul Tibbits questioned whether the FDA was moving the goalposts by demanding more evidence of benefit beyond...

The US Food and Drug Administration still supports hemoglobin A1C reduction as a regulatory endpoint for new diabetes treatments, but the risk of diabetic ketoacidosis with

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