It’s official: The European Commission has approved Forxiga® (dapagliflozin and marketed in the United States as Farxiga®) for adults with type 1 diabetes (T1D), when used in conjunction with insulin to improve glycemic control. This is the first oral medicine for T1D in Europe, and blocks SGLT, which is responsible for glucose absorption in the gastrointestinal tract. This is the first approval of Forxiga for the treatment of people with T1D. It follows a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending approval to the European Commission last month.
Forxiga was approved for people with T1D with a body mass index (BMI) above or equal to 27 kg/m2, when insulin alone does not provide adequate control despite optimal insulin therapy.
(Note that because Forxiga carries a risk for diabetic ketoacidosis (DKA), it is being recommended that everyone consults with their doctor when considering this treatment.)
The CHMP, in February, also recommended that the drug Zynquista (sotagliflozin), another SGLT inhibitor, be approved for T1D in Europe, and we are waiting on that final decision that is expected in a few months. The Zynquista submission to the U.S. Food and Drug Administration (FDA) was not approved in its present form as announced on Friday; the drug manufacturers have said they will work closely with the FDA to determine the appropriate next steps.
The Forxiga approval is a big win for the T1D community in Europe, and JDRF will continue to fight for better management tools and technologies, across the world, until a cure is found. Find out more at jdrf.org.