Zynquista approved in Europe for treating type 1 diabetes

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Zynquista (sotagliflozin) has been approved in Europe for use as an adjunct to insulin therapy to improve blood sugar control in adults with type 1 diabetes (T1D).

Developed by Sanofi and Lexicon, Zynquista is an oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-dependent glucose co-transporter types 1 and 2 (SGLT1 and SGLT2).

SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidney.

“Zynquista’s dual mechanism of action provides important treatment benefits for adults with type 1 diabetes, including reducing blood sugar reabsorption in the kidneys through SGLT2 inhibition and delaying dietary sugar absorption through local SGLT1 inhibition in the intestinal tract,” said John Reed, Global Head of Research & Development at Sanofi.

The approval is based on evidence including data from the inTandem clinical trial program, which included three Phase 3 clinical trials assessing the safety and efficacy of sotagliflozin, involving approximately 3,000 adults with inadequately controlled T1D. 4-7

These three trials demonstrated that treatment with sotagliflozin, when given to adults with inadequately controlled T1D as an oral adjunct to insulin, resulted in consistent and significant reductions from baseline at 24 weeks in average blood sugar (HbA1c), body weight, systolic blood pressure, a significant improvement of time in target blood sugar range and improved patient-reported outcomes, versus insulin alone.

Consistent with selective SGLT2 inhibitors, clinical trials with sotagliflozin showed an increased risk of genital mycotic infections and diabetic ketoacidosis (DKA), which is acknowledged to affect people with T1D more frequently than those with type 2 diabetes (T2D).

Zynquista is also currently being evaluated in a program of 11 clinical trials in adults with T2D, including two trials in people living with T2D and renal impairment, and two large cardiovascular outcomes trials.