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# Lexicon Yanks Diabetes NDA Over Technical Correction
- URL: https://www.fdaweb.com/lexicon-yanks-diabetes-nda-over-technical-correction/
- Published: 2022-02-28T12:00:00.000Z
- Updated: 2026-09-14T17:34:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151249

Lexicon Pharmaceuticals has voluntarily withdrawn its NDA for sotagliflozin, indicated for reducing the risk of cardiovascular death, hospitalization for heart failure, and urgent visits for heart failure in adult patients with Type 2 diabetes with either worsening heart failure or additional risk factors for heart failure irrespective of left ventricular ejection fraction. The company says the withdrawal will allow the company to amend the submission to correct a technical issue that was recently identified by the company. Once corrected, Lexicon says it will resubmit the NDA.

The drug has had a troubled past. In 2019, CDER issued a complete response letter to Sanofi/Lexicon stating that the NDA could not be approved because its clinical data demonstrated that the addition of sotagliflozin to insulin was associated with an increased risk of diabetic ketoacidosis (DKA), a serious and often life-threatening consequence of insulin insufficiency. Two subsequent dispute resolution requests were rejected by CDER based on the determination that the drug’s DKA risk outweighed its benefits.

After discovering the latest technical issues, Lexicon notified FDA to inquire about correcting the submission. “Due to the proximity to the conclusion of the 60-day filing review period, Lexicon determined, after consultation with the FDA, that the withdrawal of the NDA and a subsequent resubmission would be the most appropriate action to provide a complete submission for review,” the company says. The resubmission is expected in the second quarter.

Meanwhile, Lexicon says a new analysis evaluating the clinical benefit of sotagliflozin in heart failure and blood glucose control across the full range of kidney function was presented at the American Heart Association Scientific Sessions last year. “Sotagliflozin significantly reduced total cardiovascular deaths, hospitalizations for heart failure, and urgent visits for heart failure, as well as decreased hemoglobin A1c, across the full range of kidney function studied, including individuals with moderate-to-severe chronic kidney disease,” it says.