The FDA has decided not to approve Farxiga, an SGLT-2 inhibitor pill, for adults with type 1 diabetes. For now, this means that Farxiga’s manufacturer, AstraZeneca, will need to work with the FDA to understand what additional information is needed to support approval for type 1 diabetes in the US.
Farxiga is from a class of drugs called “SGLT-2 inhibitors,” a once-daily pill that causes the kidneys to excrete excess glucose through the urine. These drugs work independent of insulin, improve time-in-range, reduce body weight, and improve blood pressure. SGLT-2 inhibitors are currently approved for people with type 2 diabetes, and some people with type 1 diabetes take them “off label” (with the oversight of a medical professional).
This decision from the FDA follows a similar decision earlier this year, when the FDA also decided not to approve Zynquista, an SGLT-1/2 dual inhibitor, for people with type 1 diabetes.
In contrast, the European Medicines Agency (EMA) has approved Farxiga and Zynquista in Europe for adults with type 1 and a body mass index above 27 (see here for a BMI calculator). While we do not have the detailed reasoning behind Europe’s BMI requirement, we have heard that people with a higher BMI are at lower risk for diabetic ketoacidosis (DKA), which is the main safety concern about people with type 1 using SGLT inhibitors. (See our infographic on reducing risk for DKA here.)
For now, the timing on official approval of these drugs for type 1 diabetes in the US is unclear. It’s possible that the FDA will observe the experience in Europe and adopt similar BMI-based labeling in the US.
For more background on SGLT inhibitors for type 1 diabetes, see our previous writing: