Lexicon's revised Zynquista bid in type 1 diabetes faces lingering safety questions

Five years after being handed a complete response letter (CRL) from the FDA for its type 1 diabetes (T1D) drug Zynquista (sotagliflozin), Lexicon Pharmaceuticals faces an advisory panel later this week that will look over its resubmission in a narrower patient group. However, in briefing documents released Tuesday, FDA staff reviewers hinted that the risk of diabetic ketoacidosis (DKA) remains a concern.