FDA Approves Jardiance and Synjardy for Treating Type 2 Diabetes in Children

The U.S. Food and Drug Administration (FDA) has approved Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) as oral medications to improve blood sugar control in children aged ten and older with type 2 diabetes. This marks a significant milestone, as these approvals introduce a new class of medicines for pediatric type 2 diabetes, complementing the existing treatment option of metformin, which was approved for pediatric use in 2000. 

Children with type 2 diabetes have limited treatment options compared to adults, despite the disease progressing more rapidly in this age group. These recent approvals address the critical need for additional treatments for pediatric type 2 diabetes, providing hope for better management. Type 2 diabetes is a chronic and progressive condition characterized by the body’s inability to produce or use insulin effectively, resulting in high blood glucose levels.

According to data from the SEARCH for Diabetes in Youth study, the incidence of type 2 diabetes in children has been increasing by 4.8% annually from 2002 to 2015, and this trend is expected to continue. In 2017, the United States had approximately 28,000 cases of type 2 diabetes in children. If current trends persist, it is projected to reach around 220,000 cases by 2060, with the majority affecting minority racial and ethnic groups such as Non-Hispanic Blacks and Hispanics. 

Jardiance and Synjardy contain empagliflozin as the active ingredient, which increases glucose excretion in the urine. Synjardy also combines empagliflozin with metformin. To assess the safety and efficacy of empagliflozin in children, a double-blind, randomized, placebo-controlled trial was conducted involving 157 patients aged 10 to 17 years with poorly controlled type 2 diabetes. The participants were divided into three treatment groups for 26 weeks: empagliflozin, a DPP-4 inhibitor (linagliptin), or placebo.

At the start of the trial, 51% of the patients were using metformin alone, 40% were on a combination of metformin and insulin, 3% were using insulin alone, and 6% were not taking any diabetes medications. The trial demonstrated that empagliflozin was superior to placebo in reducing hemoglobin A1c (average blood sugar) at week 26. Patients treated with empagliflozin experienced an average decrease of 0.2% in hemoglobin A1c, while those on placebo showed an average increase of 0.7%, resulting in a net reduction of 0.8% in hemoglobin A1c with empagliflozin.

Additionally, empagliflozin-treated patients exhibited reductions in fasting plasma glucose compared to placebo patients. The common side effects observed in children treated with empagliflozin were generally similar to those reported in adults, except for a higher risk of hypoglycemia (low blood sugar) in pediatric patients aged ten and older taking empagliflozin, regardless of other diabetes therapies they were using. Common side effects associated with empagliflozin in adults include urinary tract infections and fungal infections in females. Common side effects of metformin include diarrhea, nausea, and upset stomach.

It is important to note that Jardiance and Synjardy are not recommended for patients with type 1 diabetes due to an increased risk of diabetic ketoacidosis. Additionally, they should not be used in patients with severe kidney problems or a history of serious allergic reactions to the medications. Synjardy must be avoided in patients with metabolic acidosis or diabetic ketoacidosis. 

Refer to the prescribing information for more information on the risks associated with Jardiance and Synjardy. Jardiance was initially approved by the FDA in 2014 for use in adults with type 2 diabetes to improve blood sugar control. It is also approved for reducing the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease and reducing the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure. 

Synjardy received its FDA approval in 2015 as an adjunct to diet and exercise for improving glucose control in adults with type 2 diabetes. When used as part of Synjardy, empagliflozin is approved for reducing the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease and reducing the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure. 

The FDA granted priority review designations to Jardiance and Synjardy for these recent approvals. This designation signifies that the evaluation of drug applications receives enhanced attention and resources from the FDA when the drugs if approved, would significantly improve the safety or effectiveness of treating, diagnosing, or preventing severe medical conditions. The FDA has granted Boehringer Ingelheim the approvals for Jardiance and Synjardy.