US FDA accepts supplemental new drug application for Jardiance for children 10 years and older with type 2 diabetes

Eli Lilly

8 March 2023 - The application is based on phase III results from the DINAMO trial showing Jardiance (empagliflozin) tablets significantly reduced A1c versus placebo in participants aged 10-17 living with type 2 diabetes.

The US FDA accepted a supplemental new drug application 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 have announced.

Read Eli Lilly press release

Michael Wonder

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Michael Wonder

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Medicine , US , Paediatrics , Dossier