Eli Lilly & Co. (LLY) Announces US FDA accepts supplemental New Drug Application for Jardiance® for children 10 years and older with type 2 diabetes

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Go back to Eli Lilly & Co. (LLY) Announces US FDA accepts supplemental New Drug Application for Jardiance® for children 10 years and older with type 2 diabetes

US FDA accepts supplemental New Drug Application for Jardiance® for children 10 years and older with type 2 diabetes

March 8, 2023 9:01 AM EST

The application is 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 diabetesIf approved, Jardiance would be the first SGLT2 inhibitor indicated for this vulnerable population

RIDGEFIELD, Conn. and INDIANAPOLIS, March 8, 2023 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for Jardiance® (empagliflozin) investigating a potential new indication... More