June 21, 2023 – The FDA has approved the drugs Jardiance and Synjardy to be taken by children ages 10 and older who have type 2 diabetes.
Type 2 diabetes affects more than 30,000 children in the U.S., and health officials predict that number will increase to 220,000 children by the year 2060, the FDA said in a news release.
Until now, the drug metformin has been the only other oral option available for the treatment of pediatric type 2 diabetes. Type 2 diabetes is a condition in which the body cannot properly process sugar, most of which comes from food. Both Jardiance and Synjardy contain a drug called empagliflozin, which works by increasing the release of glucose in the urine. Synjardy also contains metformin. The drugs are intended to be used along with a healthy diet and exercise.
Both drugs are already FDA-approved for use by adults with type 2. Synjardy was approved in 2015, and Jardiance was approved in 2014. In addition to helping control glucose levels, both are known to have cardiovascular benefits for adults.
The new approval was based on results from a study of 157 kids ages 10 to 17 years old with type 2 diabetes that wasn't well-controlled, the FDA said in its news release. That study concluded in May, and the FDA fast-tracked the approval of the medicine based on the results.
Health officials are concerned about the rate of children being diagnosed with type 2 diabetes. Among youths ages 10 to 19 years old, the CDC says 34 per 100,000 had the condition in 2001. That rate rose to 67 per 100,000 in 2017. Type 2 diabetes in children disproportionately affects Black, Hispanic, and American Indian children.
The Mayo Clinic says it’s unclear what causes some people to develop type 2 diabetes, although family history and genes play a role. Uncontrolled diabetes can cause heart and blood vessel problems, stroke, nerve damage, kidney disease, and vision problems, including blindness.
“Until recently, young children and teens almost never got type 2 diabetes, which is why it used to be called adult-onset diabetes,” the CDC explains on its diabetes prevention website. “Now, about one-third of American youth are overweight, a problem closely related to the increase in kids with type 2 diabetes, some as young as 10 years old.”
