The treatment of pediatric type 2 diabetes with empagliflozin (Jardiance) and empagliflozin with metformin hydrochloride (Synjardy) has been approved by the U.S. Food and Drug Administration.
The approval, which the agency announced on June 20, recommends both medicines as an adjuvant to diet and exercise to enhance glycemic control in children with type 2 diabetes aged 10 and older. This approval is the first SGLT2 inhibitor in pediatric type 2 diabetes.
"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," says associate director for therapeutic review for the Division of Diabetes, Lipid Disorders, and Obesity in the FDA's Center for Drug Evaluation and Research Michelle Carey.
She continues that the authorization will give kids with type 2 diabetes much-needed additional treatment alternatives.
In March 2023, the FDA granted the first SGLT2 inhibitor approval. The class's history is brimming with historical trials and approvals, more than ten years after the class was approved as an adjunct in type 2 diabetes for adults.
Since the class's medicines were approved in March 2013 for use in adults with type 2 diabetes, they have also been given indications for and included in treatment recommendations for heart failure and chronic renal disease.
The possibility of an oral class of drugs for enhancing glycemic control in the face of a burgeoning diabetes epidemic was warmly hailed at the presentation of the phase 3 DINAMO study at the International Diabetes Federation World Diabetes Congress 2022.
The DINAMO trial findings support the FDA's opinion that the agents should be approved. The trial, a 157-patient, double-blind, randomized, placebo-controlled study, assigned patients to empagliflozin, linagliptin, or placebo medication for 26 weeks.
It is significant that at baseline, 51% of patients were taking metformin alone, 40% were taking metformin and insulin together, 3% were using insulin alone, and 6% were not taking any other diabetic medications.
According to the trial's findings, empagliflozin usage was linked to a 0.84% decrease in HbA1c at week 26 compared to placebo therapy. Linagliptin, with a numerical reduction in HbA1c of 0.34% compared to placebo medication, was not linked to a statistically significant decrease in HbA1c.
Results showed that using empagliflozin was linked to a 35.2 mg/dL decrease in fasting plasma glucose in an examination of secondary endpoints. Boehringer Ingelheim received clearance for empagliflozin and empagliflozin with metformin hydrochloride.
For the approvals, empagliflozin and empagliflozin with metformin hydrochloride were given priority review designations. An application for a medicine that, if approved, would significantly improve the safety or efficacy of the treatment, diagnosis, or prevention of severe illnesses is given a priority review designation, focusing attention and resources on examining the application.