FDA Rejects Sotagliflozin As Insulin Add-On

On December 20, 2024, Lexicon Pharmaceuticals announced that it received a complete response letter from the FDA regarding the drug sotagliflozin (Zynquista).

The latest communication from the FDA aligns with a previously issued letter noting deficiencies regarding Lexicon’s new drug application for Zynquista as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease.

Following receipt of the earlier letter, Lexicon eliminated its commercial operations and activities for Zynquista. It also ended promotional efforts for Inpefa, a version of sotagliflozin that is approved for cardiovascular indications. However, Inpefa continues to be manufactured and made available to patients and existing prescribers.

Lexicon will concentrate its resources on the continued research and development of its pipeline, including LX9211 for diabetic neuropathic pain.

Source: Press release