FDA Approves Jardiance, Synjardy for Pediatric T2D

The FDA yesterday approved new indications for empagliflozin (Jardiance) and combination empagliflozin with metformin hydrochloride (Synjardy) for improving blood sugar control in children aged 10 and younger with type 2 diabetes (T2D), an FDA press release said.

The FDA granted these approvals to Boehringer Ingelheim.

Jardiance and Synjardy were originally approved in 2014 and 2015, respectively, as supplements to diet and exercise to improve blood sugar control in adults with T2D. Both drugs are also approved for the reduction of cardiovascular death risk in adults with both T2D and established cardiovascular disease, as well as for decreasing the risk of cardiovascular death and hospitalization due to heart failure in adults with heart failure.

There are new indications for empagliflozin (Jardiance) and combination empagliflozin with metformin hydrochloride (Synjardy) for improving blood sugar control in children aged 10 and younger with type 2 diabetes.

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This new approval expands the drugs’ indications to pediatric T2D. The only other oral drug FDA-approved for pediatric T2D is metformin, which first received approval for pediatric use in 2000.

“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 of 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.”

T2D is the most prevalent form of diabetes and is characterized by the body's inadequate production or utilization of insulin, thus leading to high glucose or sugar levels in the blood. According to the SEARCH for Diabetes in Youth study, the incidence of pediatric T2D increased by 4.8% annually between 2002 and 2015, and is expected to continue rising.

According to the press release, the United States had approximately 28,000 cases of pediatric T2D in 2017. If current trends in this area continue, experts have projected this number to reach 220,000 by the year 2060, noting that a significant portion of cases are likely to affect patients who are part of minority racial and ethnic groups.

Empagliflozin is the active ingredient in both Jardiance and Synjardy, and functions by increasing the glucose excretion in the urine.

The ingredient’s safety and efficacy in children was assessed during a double-blind, randomized, placebo-controlled trial, which included 157 patients aged between 10 and 17 years with inadequately controlled T2D. During the 26-week study, participants were assigned to 1 of 3 treatment groups: empagliflozin, the DPP-4 inhibitor linagliptin, or placebo. The trial began with 51% of participants receiving metformin alone, 40% using a combination of metformin and insulin, 3% on insulin alone, and 6% not taking any diabetes medication.

The trial was completed May 31, 2023, and was sponsored by Boehringer Ingelheim.

The study demonstrated that at 26 weeks, empagliflozin led to a superior reduction in hemoglobin A1c compared with placebo. Participants treated with empagliflozin experienced an average decrease of 0.2% in hemoglobin A1c, while those in the placebo group saw an average increase of 0.7%, reflecting a 0.8% decrease in hemoglobin A1c with empagliflozin compared with placebo. Additionally, participants receiving empagliflozin showed reductions in fasting plasma glucose levels compared with participants receiving placebo.

In children treated with empagliflozin, the commonly reported side effects were generally consistent with those observed in adults. However, there was a higher risk of hypoglycemia or low blood sugar among pediatric patients aged 10 and older who received empagliflozin, regardless of concurrent T2D therapies. Among adults, women treated with empagliflozin commonly experienced urinary tract infections and fungal infections, and he most frequently reported side effects of metformin treatment include diarrhea, nausea, and stomach discomfort.