Therapy Areas: Diabetes
Boehringer Ingelheim and Eli Lilly announce FDA acceptance of Jardiance supplemental New Drug Application
9 March 2023 -

Germany-based Boehringer Ingelheim and United States-based Eli Lilly and Company (NYSE:LLY) announced on Wednesday that the United States Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for Jardiance (empagliflozin) assessing a potential new indication to reduce blood sugar along with diet and exercise in children 10 years and older with type 2 diabetes.

The company has submitted the sNDA based on the outcome from the DINAMO phase III trial, in which Jardiance was associated with a statistically significant decrease in the primary endpoint of change from baseline in A1c (a marker of average blood sugar) at 26 weeks compared with placebo in participants aged 10-17 years with type 2 diabetes.

Mohamed Eid, MD, MPH, MHA., vice president, Clinical Development & Medical Affairs, Cardio-Renal-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc, said, 'There are clear unmet needs for young people living with type 2 diabetes, which has nearly doubled in prevalence in people aged 10-19 over the past two decades. We look forward to working closely with the FDA during the review process and while we await a decision on our efforts to bring another potential treatment option to children 10 years and older with type 2 diabetes.'