FDA Advisory Committee Votes Against Zynquista for Type 1 Diabetes and Chronic Kidney Disease, Despite Support for Subgroup Benefits

FDA Advisory Committee Vote:
The FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 11 to 3 against Zynquista, concluding that its benefits do not outweigh the risks in adults with T1D and CKD.

Subgroup Support:
Despite the negative vote, some committee members expressed support for Zynquista in alternative sub-populations of T1D and CKD patients, where they believed the benefits potentially outweigh the risks.

Unmet Medical Need:
Only 20% of T1D patients achieve adequate glycemic control with insulin alone, highlighting a significant unmet medical need for additional therapies like Zynquista.

PDUFA Date:
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 20, 2024, for the review of Zynquista's New Drug Application.

Previous Rejection:
Zynquista was previously rejected by the FDA in 2019 for the treatment of T1D due to concerns about elevated risk for diabetic ketoacidosis.

Current Approval:
Sotagliflozin is currently approved by the FDA under the brand name Inpefa for reducing the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in patients with heart failure or type 2 diabetes, CKD, and other cardiovascular risk factors.