FDA Accepts Lexicon NDA for Resubmitted Diabetes Drug

FDA has accepted for review a resubmitted Lexicon Pharmaceuticals NDA for Zynquista (sotagliflozin) as an adjunct to insulin therapy for glycemic control in adults with Type 1 diabetes and chronic kidney disease (CKD). The agency indicated that it considers the resubmission to be a complete response to its 2019 complete response letter. FDA has set a 12/20 user fee review action target date.

Sanofi-aventis, Lexicon’s predecessor-in-interest, submitted the original NDA 3/2018, and in 3/2019 CDER issued a complete response letter, citing deficiencies such as data demonstrating that the addition of sotagliflozin to insulin is 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 a determination that the drug’s DKA risk outweighed its benefits.