In a second win for the type 1 diabetes (T1D) community, the European Commission has approved Zynquista™ (sotagliflozin) for use in adults with T1D with a body mass index (BMI) above or equal to 27 kg/m2, in combination with insulin to improve blood-sugar control. It and Forxiga® (dapagliflozin and marketed in the United States as Farxiga®), which was approved by the European Commission in March, are SGLT inhibitors. The approval provides another option to improve daily blood-sugar management in people with T1D.
As part of our mission to accelerate life-changing breakthroughs, Breakthrough T1D was one of the first to support an early clinical trial of Zynquista to see if the drug worked for people with T1D. In this and later clinical trials, the drug showed a significant reduction in blood-sugar levels, and also improved other key health measures, such as time in range, body weight and blood pressure, contributing to better outcomes for many people with T1D. For some people with the disease, using SGLT inhibitor therapies such as Zynquista means also taking less insulin.
The SGLT inhibitors also bring risks, however, including dehydration, constant urination, urinary tract infections and the life-threatening condition, diabetic ketoacidosis (DKA). Because of these risks, Zynquista (sotagliflozin) may not be appropriate for use in everyone with T1D. We urge you to talk with your doctor about whether or not this treatment is right for you.
The Zynquista submission to the U.S. Food and Drug Administration (FDA) was not approved in its present form as announced in March; the drug manufacturers have said they will work closely with the FDA to determine the appropriate next steps.
The Zynquista approval is a big win for the T1D community in Europe, and Breakthrough T1D will continue to fight for better management tools and technologies, across the world, until a cure is found. Find out more at BreakthroughT1D.org.
