FDA accepts sNDA for empagliflozin in children with type 2 diabetes

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A supplemental New Drug Application for empagliflozin (Jardiance; Boehringer Ingelheim and Eli Lilly and Company) in pediatric patients with type 2 diabetes has been accepted by the FDA.

The FDA has accepted a supplemental New Drug Application (sNDA) for empagliflozin (Jardiance; Boehringer Ingelheim and Eli Lilly and Company) to lower blood sugar in children aged 10 years and older with type 2 diabetes.

Safety and efficacy outcomes were proven in the DINAMO (NCT03429543) phase 3trial, testing the results of empagliflozin when applied alongside diet and exercise. Participants included pediatric patients aged 10 to 17 years with type 2 diabetes. 

Patients were randomly assigned to an empagliflozin, linagliptin (Tradjenta; Boehringer Ingelheim Pharmaceuticals), or placebo group. If participants in the empagliflozin group did not have reduced levels of A1c, a marker of average blood sugar, below 7% by week 12, they were randomized to continue taking 10mg empagliflozin or switch to 25 mg.

A significant reduction in blood sugar at 26 weeks was found in more patients in the empagliflozingroup compared to the placebo group. A1c was reduced by 0.84% more in patients using empagliflozin alongside diet and exercise than those using placebo. In comparison, linagliptin did not lead to a significant reduction in A1c.

Safety data recorded in the DINAMO trial was tested until week 52 and was consistent with the established safety profile for empagliflozin. Potential adverse events include ketoacidosis, dehydration, serious urinary tract infections, low blood sugar, necrotizing fasciitis, vaginal yeast infection, yeast infection of the penis, and allergic reactions.

Currently, empagliflozin is used in adults with type 2 diabetes. A tablet is taken once per day to lower blood sugar levels and reduce the risk of cardiovascular death. It should not be used in patients with type 1 diabetes.

According to Jeff Emmick, MD, PhD, vice president of product development at Lilly, about 39,000 people aged under 20 years are impacted by type 2 diabetes. If approved, empagliflozin would be a new oral treatment option for type 2 diabetes in children 10 years and older in the United States.

Reference

US FDA accepts supplemental New Drug Application for Jardiance for children 10 years and older with type 2 diabetes. Lilly Investors. March 8, 2023. Accessed March 8, 2023. https://investor.lilly.com/news-releases/news-release-details/us-fda-accepts-supplemental-new-drug-application-jardiancer-1

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