Lexicon Refiling NDA for Sotagliflozin in Diabetes

Lexicon Pharmaceuticals says that after receiving recent FDA feedback it plans to resubmit its NDA for sotagliflozin oral tablets, 200 milligrams (mg) and 400 mg, as an adjunct to insulin therapy in patients with Type 1 diabetes and chronic kidney disease. In 2021, CDER issued a Federal Register notice proposing to refuse to approve the NDA in its present form.

Sanofi-aventis, Lexicon’s predecessor-in-interest, submitted the original NDA 3/2018, and in 3/2019 CDER issued a complete response letter on the submission, 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 the determination that the drug’s DKA risk outweighed its benefits.