BRIEF—FDA accepts sNDA for Jardiance

The US Food and Drug Administration (FDA) 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.

The drug is marketed by Germany’s Boehringer Ingelheim in partnership with US pharma major Eli Lilly.

If approved, Jardiance would be the first SGLT2 inhibitor indicated for this vulnerable population, the companies noted.

The application is based on phase III results from the DINAMO trial showing Jardiance tablets significantly reduced A1c (a marker of average blood sugar) versus placebo in participants aged 10-17 living with type 2 diabetes.