FDA to Hold Advisory Committee Meeting for Sotagliflozin in Type 1 Diabetes and CKD

The FDA will convene a meeting on Oct. 31, 2024, of the Endocrinologic and Metabolic Drugs Advisory Committee to discuss Zynquista (sotagliflozin) as an adjunct to insulin to help control glycemic levels in adults with type 1 diabetes and chronic kidney disease (CKD). The agency’s goal date is Dec. 20, 2024.

Developed by Lexicon Pharmaceuticals, sotagliflozin is an inhibitor of SGLT2 and SGLT1, which are responsible for glucose regulation in the kidney and gastrointestinal tract, respectively. Lexicon officials have not indicated what regulatory officials would like the advisory committee to discuss regarding the application of Zynquista.

Lexicon had resubmitted the application for sotagliflozin in the diabetes indication in June 2024. The FDA had issued a complete response letter in 2019 regarding the NDA for sotagliflozin.

Sotagliflozin was approved by the FDA as Inpefa in May 2023 as a once-daily oral tablet that reduces the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure or type 2 diabetes, chronic kidney disease, and other cardiovascular risk factors.

The wholesale acquisition cost of Inpefa is $598 per month. A $10 copay card for Inpefa is available that would cover up to $2,600 in costs per year.

Mike Exton, Ph.D.

“If approved, this will mark Lexicon’s second NDA approval and commercial launch in two years of products that originated from our novel discovery platform and advanced to regulatory approval and commercialization,” Mike Exton, Ph.D., said in a news release in July 2024.

For the first half of 2024, Inpefa generated sales of $2.7 million. Inpefa is the company’s only revenue-generating product. For the full year 2023, Inpefa generated sales of $1.2 million.

Data were presented in March 2024 from the inTandem3 phase 3 trial. The trial found that treatment with sotagliflozin resulted in improved glycemic control in patients with type 1 diabetes and chronic kidney disease (CKD). Sotagliflozin successfully lowered A1C, body weight, and systolic blood pressure with safety similar to the total study cohort.

Using data from the 24-week trial, the effects of sotagliflozin 400 mg daily added to insulin therapy on A1C, body weight, systolic blood pressure, eGFR, total insulin dose, adjudicated severe hypoglycemia and DKA were evaluated in a subgroup of 228 patients with type 1 diabetes and CKD.

Compared with placebo, treatment with sotagliflozin led to similar reductions in A1C, body weight and systolic blood pressure in the CKD and total cohorts. Sotagliflozin was associated with similar risks of severe hypoglycemia between the two cohorts.

Additionally, a registrational phase 3 study is under way of sotagliflozin to treat patients with hypertrophic cardiomyopathy (HCM), a condition that impacts the left ventricle of the heart, making it hard for the heart to pump blood.