FDA approves Jardiance and Synjardy for pediatric use.
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.
Michelle Carey, M.D.
“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.