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The FDA's historic June 20, 2023 approval of empagliflozin (Jardiance) and empagliflozin plus metformin hydrochloride (Synjardy) marks the first pediatric type 2 diabetes indication for the SGLT2 inhibitor class and comes less than a year after the debut of DINAMO data.
The US Food and Drug Administration has announced the approval of empagliflozin (Jardiance) and empagliflozin plus metformin hydrochloride (Synjardy) for the treatment of pediatric type 2 diabetes.
Announced by the agency on June 20, 2023, the approval which indicates both agents as an adjunct to diet and exercise to improve glycemic control in children 10 years and older with type 2 diabetes, marks the first approval for an 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,” said 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. “Today’s approvals provide much-needed additional treatment options for children with type 2 diabetes.”
The first FDA approval for SGLT2 inhibitors dates back to March 2023. Now, more than a decade after the class received approval as an adjunct in type 2 diabetes for adults, the class’s story is one bursting with historic trials and approvals. Since the March 2013 approval in adults with type 2 diabetes, agents in the class has received indications for and been included in guidelines pertaining to the treatment of heart failure and chronic kidney disease.
In the face of a ballooning diabetes epidemic, the potential of an oral class of medications for improving glycemic control was welcomed with open arms during the presentation of the phase 3 DINAMO trial at the International Diabetes Federation World Diabetes Congress 2022. According to the statement from the FDA, the results of the DINAMO trial support approval of the agents.
A double-blind, randomized, placebo-controlled trial in 157 patients aged 10-17 years, the DINAMO trial randomized patients to empagliflozin, linagliptin, or placebo therapy for 26 weeks. Of note, at baseline, 51% of patients were taking metformin alone, 40% of patients were taking a combination of metformin and insulin, 3% of patients were taking insulin alone, and 6% of patients were not taking other medicines for diabetes.
Results of the trial suggested use of empagliflozin was associated with a 0.84% reduction in HbA1c relative to placebo therapy at week 26 (95% CI –1.50 to –0.19; P = .012). Investigators also pointed out use of linagliptin was not associated with a statistically significant reduction in HbA1c compared with placebo therapy, with a numerical reduction of 0.34% (P=.2935). In an analysis of secondary endpoints, results indicated use of empagliflozin was associated with a 35.2 mg/dL reduction in fasting plasma glucose (P=.0035).
The approval of empagliflozin and empagliflozin plus metformin hydrochloride were awarded to Boehringer Ingelheim. In their announcement, the FDA noted the most common side effects in patients treated with metformin include diarrhea, nausea, and upset stomach.
“As the burden of type 2 diabetes increases among young people, so does the need for additional treatment options with proven clinical benefits,” said Lennart Jungersten, MD, PhD, senior vice president of Medicine and Regulatory Affairs at Boehringer Ingelheim.4 “This FDA approval, which is based on the efficacy results and safety data from the DINAMO trial, 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.”