The U.S. Food and Drug Administration accepted a supplemental New Drug Application (sNDA) for Jardiance (empagliflozin) investigating a potential new indication to lower blood sugar along with diet and exercise in children 10 years and older with type 2 diabetes, Boehringer Ingelheim and Eli Lilly and Co. (LLY) said in a statement.
The application was based on phase III results from the DINAMO trial showing Jardiance (empagliflozin) tablets significantly reduced A1c (a marker of average blood sugar) versus placebo in participants aged 10-17 living with type 2 diabetes.
If approved, Jardiance would be the first SGLT2 inhibitor indicated for the vulnerable population, the company said.
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