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# Advisors Asked About Lexicon’s Sotagliflozin
- URL: https://www.fdaweb.com/advisors-asked-about-lexicons-sotagliflozin/
- Published: 2024-10-30T12:00:00.000Z
- Updated: 2026-09-14T14:45:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158089

In advance of the 10/31 meeting of the FDA Endocrinologic and Metabolic Drugs Advisory Committee meeting to discuss the Lexicon Pharmaceuticals resubmitted NDA for sotagliflozin (Zynquista), the agency released a briefing document with questions for the committee to consider. The [document](https://www.fda.gov/media/183160/download?ref=fdaweb.com) says Lexicon is proposing an indication for Zynquista as an adjunct to insulin therapy to improve glycemic control in adults with Type 1 diabetes and chronic kidney disease.

A previous submission sought an indication as an adjunct to insulin to improve glycemic control in adults with Type 1 diabetes. The document says that submission received a complete response letter because FDA determined that the risk of diabetic ketoacidosis outweighed the benefits for the proposed indication and patient population.

“FDA seeks advice from the advisory committee on whether the data in the revised NDA support an overall favorable benefit-risk assessment for sotagliflozin for the revised indication to limit the population to patients with Type 1 diabetes and chronic kidney disease,” CDER medical reviewers write in the briefing document. Draft points for committee consideration are:

- the adequacy of the existing clinical trial data to support a conclusion that Zynquista improves glycemic control across the range included in the indication proposed by Lexicon;
- the adequacy of the existing data to support a conclusion that the magnitude of the diabetic ketoacidosis risk in patients with Type 1 diabetes and chronic kidney disease treated with Zynquista can be assumed to be similar to that observed in patients with Type 1 diabetes in the overall TANDEM trial;
- the scientific rationale justifying extrapolation of the demonstrated benefit of Zynquista to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure in specified patients; and
- the overall benefit/risk assessment for Zynquista for its proposed indication.