FDA Clears Jardiance and Synjardy for Kids with Type 2 Diabetes

The FDA has approved Boehringer Ingelheim and Lilly’s Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin) to improve blood sugar control in children 10 years and older with type 2 diabetes, marking a new class of medicines taken by mouth to treat pediatric type 2 diabetes.

Metformin, the only other oral therapy available for the treatment of children with type 2 diabetes, was first approved for pediatric use in 2000.

“Compared with adults, children with type 2 diabetes have limited treatment options, even though the disease and symptom onset generally progress more rapidly in children,” Michelle Carey, M.D., M.P.H., associate director for therapeutic review for the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, said in a press release.

The FDA approval “marks an important milestone in helping address a clear unmet need for oral treatment options, in addition to metformin, to lower A1c in this rapidly rising population,” Lennart Jungersten, M.D., Ph.D., senior vice president of Medicine & Regulatory Affairs at Boehringer Ingelheim, said in a press release.

The blockbuster diabetes medication Jardiance was also granted an additional heart failure indication in February 20226. The current list price for a month supply of Jardiance is $570.48.

The FDA accepted the supplemental new drug application (sNDA) for Jardiance to lower blood sugar in children 10 years and older with type 2 diabetes in early March.

As of 2017, there were about 28,000 cases of type 2 diabetes in children in the United States, according to the FDA. “By 2060, if current trends continue, that number is predicted to be about 220,000, with the majority of cases occurring in minority racial and ethnic groups such as Non-Hispanic Blacks and Hispanics,” the agency said.

The safety and efficacy of empagliflozin in children were studied in a double-blind, randomized, placebo-controlled trial in 157 children 10 to 17 years with inadequately controlled type 2 diabetes. At week 26, treatment with empagliflozin was superior in reducing hemoglobin A1c compared with placebo. The 52 patients treated with empagliflozin had an average 0.2% decrease in hemoglobin A1c compared with an average 0.7% increase in hemoglobin A1c in the 53 patients taking placebo — a 0.8% decrease in hemoglobin A1c with empagliflozin as compared to placebo.

Patients treated with empagliflozin also had reductions in fasting plasma glucose, a blood sugar measurement taken after not eating or drinking for at least eight hours, as compared to patients taking placebo, the FDA said.

Common side effects in children were generally similar to those reported in adults, except there was a higher risk of hypoglycemia (low blood sugar), regardless of whether they were taking other therapies for diabetes, the FDA said.

Jardiance was originally approved by the FDA in 2014 to improve blood sugar control in adults with type 2 diabetes. In February 2022, Jardiance was also approved to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease, and to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure.

Synjardy was originally approved by the FDA in 2015 to improve glucose control in adults with type 2 diabetes.