FDA Accepts Lexicon’s Resubmitted NDA for Sotagliflozin Heart Failure Drug

The FDA has accepted Lexicon Pharmaceuticals’ resubmitted New Drug Application (NDA) for sotagliflozin to treat heart failure.

Sold under the brand name Zynquista, sotagliflozin is approved in the European Union for treatment of type 1 diabetes.

The company received a Complete Response Letter from the FDA in March 2019, declining to approve the drug as an adjunct treatment for adult patients with type 1 diabetes in combination with insulin to improve glycemic control.

The FDA said the data submitted with the original NDA did not show that sotagliflozin is safe under the proposed conditions of use. In particular, the agency was concerned about the increased risk of diabetic ketoacidosis, a serious and often life-threatening consequence of insulin insufficiency.

The agency has set a decision date of May 2023 on the resubmitted NDA.