The New Drug Application (NDA) for Zynquista (sotagliflozin; Sanofi and Lexicon) has been accepted by the Food and Drug Administration (FDA), with a Prescription Drug User Free Act (PDUFA) action date set for March 22, 2019.
Zynquista is an investigational dual sodium-glucose co-transporter types 1 and 2 (SGLT1, SGLT2) inhibitor, intended for use with insulin to improve glycemic control in adults with type 1 diabetes. It works by inhibiting the two proteins responsible for glucose regulation: SGLT1 (responsible for glucose absorption in the GI tract) and SGLT2 (responsible for glucose reabsorption by the kidney).
The NDA was supported by data from the Phase 3 inTandem clinical trial program which assessed the safety and efficacy of Zynquista in ~3000 adults with inadequately controlled type 1 diabetes.
“If approved, our dual SGLT-1 and SGLT-2 inhibitor, Zynquista, would be the first approved oral therapy used in combination with insulin to improve glycemic control and patient outcomes for adults in the United States who are living with type 1 diabetes,” said Pablo Lapuerta, MD, executive vice president and chief medical officer, Lexicon. “The acceptance of the NDA filing moves us closer to providing a meaningful option for people with type 1 diabetes and we look forward to continuing to work closely with the FDA during the review process.”