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The U.S. Food and Drug Administration granted approval to Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) as supplementary treatments to diet and exercise. These medications aim to enhance blood sugar control in children aged 10 years and above who are diagnosed with type 2 diabetes. This recent approval signifies the introduction of a new class of orally administered medicines specifically designed to address pediatric type 2 diabetes. Previously, the only oral therapy option available for treating children with type 2 diabetes was metformin, which obtained pediatric approval in the year 2000.
Michelle Carey, M.D., M.P.H., who serves as the associate director for therapeutic review for the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, expressed the limited treatment choices available to children with type 2 diabetes in comparison to adults. She highlighted the faster progression of the disease and symptoms in children. Dr. Carey emphasized the significance of the recent approvals, stating that they offer essential additional treatment alternatives that are much-needed for children diagnosed with type 2 diabetes.
Type 2 diabetes, the most prevalent form of diabetes, is a chronic and progressive condition characterized by impaired insulin production or utilization, resulting in elevated blood glucose (sugar) levels. The SEARCH for Diabetes in Youth study has revealed that the incidence of type 2 diabetes among children rose by 4.8% annually between 2002 and 2015, and this upward trend is expected to persist. In 2017, approximately 28,000 cases of type 2 diabetes were reported in children across the United States. If current patterns persist, projections suggest that by 2060, this figure could escalate to around 220,000 cases, with a higher prevalence among minority racial and ethnic groups, including Non-Hispanic Blacks and Hispanics. The active ingredient in Jardiance and Synjardy, empagliflozin, functions by promoting the excretion of glucose in the urine. Additionally, Synjardy combines empagliflozin with metformin.
A rigorous double-blind, randomized, and placebo-controlled trial was conducted to assess the safety and effectiveness of empagliflozin in pediatric patients aged 10 to 17 years with inadequately controlled type 2 diabetes. The study involved 157 participants who were randomly assigned to one of three treatment groups over a span of 26 weeks: empagliflozin, a DPP-4 inhibitor called linagliptin, or placebo. At the beginning of the trial, 51% of patients were solely taking metformin, 40% were using a combination of metformin and insulin, 3% were using insulin alone, and 6% were not taking any other diabetes medications.
Results from the trial demonstrated that empagliflozin treatment was significantly superior to placebo in terms of reducing hemoglobin A1c levels, which serves as an indicator of average blood sugar levels. The group of 52 patients who received empagliflozin exhibited an average decrease of 0.2% in hemoglobin A1c, while the placebo group of 53 patients experienced an average increase of 0.7% in hemoglobin A1c, resulting in a notable 0.8% decrease in hemoglobin A1c with empagliflozin compared to placebo. Furthermore, patients treated with empagliflozin demonstrated reductions in fasting plasma glucose levels, a measurement of blood sugar taken after at least eight hours of fasting, in comparison to those receiving placebo.
In children treated with empagliflozin, the common side effects observed were generally comparable to those reported in adults. However, it’s worth noting that pediatric patients aged 10 years and older who were administered empagliflozin had a higher likelihood of experiencing hypoglycemia (low blood sugar) compared to those on placebo, irrespective of whether they were concurrently undergoing other diabetes treatments.
Among adults treated with empagliflozin, the most commonly reported side effects encompass urinary tract infections and fungal infections in females. As for patients undergoing metformin treatment, the most frequently observed side effects consist of diarrhea, nausea, and stomach upset. It is important to note that Jardiance and Synjardy are not recommended for individuals with type 1 diabetes due to the heightened risk of diabetic ketoacidosis. Moreover, these medications should not be utilized to improve blood sugar control in patients with severe kidney problems, and they must be avoided in individuals who have previously experienced a severe allergic reaction to them. Specifically, Synjardy must not be administered to patients with metabolic acidosis or diabetic ketoacidosis, characterized by increased levels of ketones in the blood or urine.
Initially, the FDA granted approval to Jardiance in 2014 as an adjunct to diet and exercise for enhancing blood sugar control in adults diagnosed with type 2 diabetes. Additionally, Jardiance has received approval for reducing the risk of cardiovascular death in adults with type 2 diabetes and existing cardiovascular disease. It is also authorized for lowering the risk of cardiovascular death and hospitalization due to heart failure in adults with heart failure.
The FDA initially approved Synjardy in 2015 as a supplementary treatment to diet and exercise for enhancing glucose control in adults diagnosed with type 2 diabetes. When empagliflozin is included as part of the Synjardy medication, it is approved for reducing the risk of cardiovascular death in adults with type 2 diabetes and pre-existing cardiovascular disease. Furthermore, it is also approved for lowering the risk of cardiovascular death and hospitalization related to heart failure in adults with heart failure.
For today’s approvals, both Jardiance and Synjardy were granted priority review designations. This designation ensures that thorough attention and resources are dedicated to the evaluation of drug applications that, if approved, would represent significant advancements in the safety or effectiveness of treatments, diagnoses, or preventive measures for serious medical conditions.
Source: FDA
