FDA Advisory Committee to Review Sotagliflozin for Type 1 Diabetes and Chronic Kidney Disease
Key Insights
The FDA's Endocrinologic and Metabolic Drugs Advisory Committee will convene on October 31, 2024, to discuss sotagliflozin for adults with type 1 diabetes (search) and chronic kidney disease (search).
Lexicon Pharmaceuticals resubmitted the NDA for sotagliflozin in June 2024, with a Prescription Drug User Fee Act (PDUFA) goal date set for December 20, 2024.
Phase 3 trial data showed sotagliflozin improved glycemic control in patients with type 1 diabetes (search) and chronic kidney disease (search), reducing HbA1c, body weight, and systolic blood pressure.
The FDA's Endocrinologic and Metabolic Drugs Advisory Committee is scheduled to meet on October 31, 2024, to discuss Lexicon Pharmaceuticals' sotagliflozin (Zynquista) as an adjunct to insulin therapy for managing glycemic levels in adults with type 1 diabetes (search) (T1D) and chronic kidney disease (search) (CKD). The Prescription Drug User Fee Act (PDUFA) goal date for this application is December 20, 2024.
Sotagliflozin is a dual inhibitor of sodium glucose cotransporters 2 (search) (SGLT2) and 1 (SGLT1), which play key roles in glucose regulation in the kidneys and gastrointestinal tract, respectively. Lexicon Pharmaceuticals has not disclosed the specific concerns or questions the FDA advisory committee will address regarding the new drug application (NDA).
Mike Exton, PhD, chief executive officer and director of Lexicon Pharmaceuticals, stated, "Lexicon looks forward to the opportunity to share the breadth of evidence that has been generated to support the favorable benefit/risk profile of sotagliflozin for glycemic control in people with type 1 diabetes (search) and CKD."
Regulatory Background
Lexicon resubmitted the NDA for sotagliflozin for the diabetes indication in June 2024, following a complete response letter from the FDA in 2019 after the initial filing. Sotagliflozin received FDA approval as Inpefa in May 2023 as a once-daily oral tablet to reduce the risk of cardiovascular death and hospitalization for heart failure (search) in adults with heart failure or type 2 diabetes, CKD, and other cardiovascular risk factors.
Clinical Trial Data
Data presented in March 2024 from the phase 3 inTandem3 clinical trial demonstrated that sotagliflozin treatment led to improved glycemic control in patients with type 1 diabetes (search) and chronic kidney disease (search). The trial showed that sotagliflozin effectively reduced HbA1c levels, body weight, and systolic blood pressure, with a safety profile consistent with the overall study population.
A post-hoc analysis of the 24-week inTandem3 trial evaluated the effects of sotagliflozin 400 mg daily, added to insulin therapy, on HbA1c, body weight, systolic blood pressure, eGFR, total insulin dose, adjudicated severe hypoglycemia, and DKA in a subgroup of 228 patients with type 1 diabetes (search) and CKD (eGFR <60 mL/min/1.73 m2 and/or UACR ≥30 mg/g).
Results indicated that sotagliflozin treatment, compared to placebo, resulted in similar reductions in HbA1c, body weight, and systolic blood pressure in both the CKD and total cohorts. The risk of severe hypoglycemia was also comparable between the two groups.
Lexicon's Perspective
"Lexicon has continued confidence in the favorable benefit/risk profile of sotagliflozin for adults with type 1 diabetes (search) and CKD. With a PDUFA date now in hand, we can begin the next phase of launch preparation for Zynquista," said Mike Exton.