FDA approves empagliflozin for use among children with type 2 diabetes
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Key takeaways:
- The FDA approved empagliflozin and empagliflozin and metformin hydrochloride for children with type 2 diabetes.
- Empagliflozin follows metformin as the second approved oral pediatric type 2 diabetes treatment.
The FDA has approved two forms of empagliflozin as an adjunct to diet and exercise to improve glycemic control in children with type 2 diabetes, according to a press release.
Empagliflozin (Jardiance, Boehringer Ingelheim/Eli Lilly) and empagliflozin and metformin hydrochloride (Synjardy, Boehringer Ingelheim/Eli Lilly) both received approval for use among children aged 10 years and older with type 2 diabetes. Empagliflozin is the second oral therapy approved for children with type 2 diabetes, following metformin, which was originally approved for use among children in 2000, according to the press release.
“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,” Michelle Carey, MD, MPH, 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. “[These] approvals provide much-needed additional treatment options for children with type 2 diabetes.”
In a double-blind, randomized, placebo-controlled trial, 157 children and adolescents aged 10 to 17 years with uncontrolled type 2 diabetes were randomly assigned to empagliflozin, linagliptin (Tradjenta, Boehringer Ingelheim/Eli Lilly) or placebo. At 26 weeks, children receiving empagliflozin had a 0.2% reduction in HbA1c compared with a 0.7% increase in the placebo group. Children receiving empagliflozin also had a greater reduction in fasting plasma glucose than placebo.
As Healio previously reported, empagliflozin was originally approved by the FDA for use among adults with type 2 diabetes in 2014, with empagliflozin and metformin hydrocholoride being approved for adults with type 2 diabetes in 2015.
Adverse events with empagliflozin are similar with children as what was reported for adults, though children had a higher risk for hypoglycemia compared with placebo in the trial, regardless of whether they were taking other diabetes therapies.
The most common adverse events for adults treated with empagliflozin include urinary tract infections and female fungal infections. Empagliflozin is not recommended for people with type 1 diabetes due to an increased risk for diabetic ketoacidosis.
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