Lexicon Loses FDA Panel Vote on Type 1 Diabetes Insulin Adjunct

Lexicon Pharmaceuticals faced a setback as the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted against the approval of its investigational type 1 diabetes drug, sotagliflozin. The committee, comprising external experts, concluded in an 11-3 vote that the clinical data provided by Lexicon was insufficient to confirm that the benefits of the drug outweigh its associated risks. The company had proposed sotagliflozin as an add-on therapy to insulin for managing blood glucose levels in patients with type 1 diabetes and chronic kidney disease.

Mike Exton, CEO of Lexicon Pharmaceuticals, expressed disappointment over the committee's decision. He highlighted the need for an FDA-approved treatment and better education on risk management. Despite the setback, Exton noted the positive discussions and support from the diabetes community during the meeting.

Sotagliflozin functions as a dual inhibitor of the SGLT2 and SGLT1 proteins, which are involved in glucose absorption in the kidney and gastrointestinal tract. Lexicon had supported its drug application with data from three pivotal Phase III trials, which showed improvements in glycemic control and body weight. However, numerous panelists were unconvinced by the presented data. Cecilia Low Wang, a professor of medicine at the University of Colorado, expressed concern regarding the small sample size and the necessity for a more robust trial to demonstrate that the drug's benefits exceed the risks.

Low Wang emphasized the need for an effective adjunctive therapy for type 1 diabetes but stated that approving a drug with minimal supportive data would not be beneficial for patients. Other experts, including Connie Newman from New York University School of Medicine, echoed this sentiment. Newman pointed out that further data was needed, particularly for patients with mild kidney damage or earlier-stage disease (eGFR values from 60 to less than 90), where sotagliflozin could potentially be more advantageous.

This recent advisory committee decision followed a previous regulatory hurdle in 2019 when the FDA issued a Complete Response Letter for sotagliflozin. At that time, the advisory committee had been evenly divided on the drug's approval, with many experts expressing doubts about its risk-benefit profile.

Currently, the FDA is reviewing Lexicon’s application for sotagliflozin and is expected to announce its decision by December 20. Although the advisory committee’s vote is non-binding, the FDA generally considers such recommendations in its final decision. The outcome remains uncertain, and Lexicon awaits the FDA's verdict on whether sotagliflozin will become an approved treatment option for patients with type 1 diabetes and chronic kidney disease.