FDA Approves New Diabetes Medications for Children

Newly Approved Drugs: Jardiance and Synjardy

In June 2023, the US Food and Drug Administration (FDA) granted approval for two medications, Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride), for the treatment of type 2 diabetes in children aged 10 and older. While over 35 medications are available for adults, children previously had limited access, primarily relying on metformin.

Michelle Carey, M.D., M.P.H., associate director for therapeutic review in the Division of Diabetes, Lipid Disorders and Obesity, stated, “Compared to adults, children with type 2 diabetes have limited treatment options, even though the disease and symptom onset generally progress more rapidly in children.” The approval of these new drugs is based on a 2023 study published in The Lancet Diabetes and Endocrinology, which indicated that Jardiance effectively reduces blood sugar levels in children after a 26-week period.

Understanding Type 2 Diabetes

Type 2 diabetes occurs when the body struggles to regulate blood sugar levels due to insufficient insulin production or utilization. Elevated blood sugar can lead to damage in blood vessels, which in turn can deprive vital organs of oxygen. If unmanaged, diabetes can result in severe health complications such as kidney failure, heart disease, vision loss, and stroke.

Risk Factors for Type 2 Diabetes

Type 2 diabetes typically manifests gradually and is closely associated with high body fat percentages, with obesity being the primary risk factor. Genetic predisposition also plays a significant role in the development of the disease, making individuals with a family history of diabetes more susceptible. Certain populations, including those of Asian and African-Caribbean descent, may experience diabetes onset at lower body fat levels, potentially due to historical famines affecting genetic traits.

Diabetes in Children

Childhood type 2 diabetes is relatively rare, with a reported incidence in Canada of 1.84 cases per 100,000. This condition often has a genetic basis, alongside lifestyle factors. Children who develop type 2 diabetes have usually experienced an accelerated progression of the disease, leading to increased risks of serious health issues if not managed appropriately.

Challenges in Managing Childhood Type 2 Diabetes

The first line of treatment for type 2 diabetes in children typically involves dietary changes and exercise to lower blood sugar levels. While these lifestyle modifications can be effective and sometimes reverse the condition, sustaining long-term changes can be challenging, particularly for children. Given the rapid progression of type 2 diabetes in youth, medications like Jardiance and Synjardy may provide essential support while children work on weight management.

Jardiance’s Impact on Blood Sugar Levels

The study involving 157 participants aged 10 to 17 aimed to evaluate the effectiveness of Jardiance compared to a placebo. After 26 weeks, the A1C scores of children receiving the placebo increased by an average of 0.7%, while those on Jardiance experienced a reduction of 0.2%. This translates to an overall average decrease in A1C scores of 0.8%, which can significantly improve blood sugar control.

Mechanism of Action for Empagliflozin

Both Jardiance and Synjardy contain empagliflozin, which works by facilitating the expulsion of excess sugar through the kidneys. This approach differs from metformin, which lowers blood sugar by acting on the intestines and liver. Since metformin can cause digestive discomfort, empagliflozin presents a gentler alternative for younger patients, with fewer gastrointestinal side effects.

Alternatives to Metformin

With the FDA’s recent approval of Jardiance and Synjardy for treating type 2 diabetes in adolescents, healthcare providers now have additional options for young patients who may experience side effects from metformin. Early intervention is crucial, as untreated type 2 diabetes can lead to severe complications such as kidney disease, heart disease, and increased mortality risk.

Kerri Z. Delaney
References:
Food and Drug Administration. FDA Approves New Class of Medicines to Treat Pediatric Type 2 Diabetes. Published June 20, 2023.
Laffel LM, Danne T, Klingensmith GJ, et al. Efficacy and safety of the SGLT2 inhibitor empagliflozin versus placebo in young people with type 2 diabetes (DINAMO): a phase 3 trial. The Lancet Diabetes & Endocrinology. 2023.
National Institute of Diabetes and Digestive and Kidney Diseases.
Diabetes in Canada. Government of Canada; 2023.
Pulgaron ER, Delamater AM. Obesity and Type 2 Diabetes in Children: Epidemiology and Treatment. Curr Diab Rep. 2014.