This site is intended for healthcare professionals
Latest drug news
  • Home
  • /
  • News
  • /
  • 2023
  • /
  • 3
  • /
  • FDA accepts sNDA for Jardiance for children 10 yea...

FDA accepts sNDA for Jardiance for children 10 years and older with type 2 diabetes.- Boehringer + Eli Lilly.

Read time: 1 mins
Published:9th Mar 2023

Boehringer Ingelheim and Eli Lilly and Company announced that the 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.


“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,” said Mohamed Eid, M.D., M.P.H., M.H.A., vice president, Clinical Development & Medical Affairs, Cardio-Renal-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc. “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.”

The sNDA is based on the results from the DINAMO phase III trial, in which Jardiance was associated with a statistically significant reduction in the primary endpoint of change from baseline in A1c at 26 weeks compared with placebo in participants aged 10-17 years with type 2 diabetes. When added to other baseline treatments (diet, exercise, metformin and/or insulin), Jardiance 10 mg and 25 mg pooled doses reduced A1c by 0.84% compared with placebo at week 26 (95% CI -1.50 to -0.19; P=0.012). Reduction in A1c in participants treated with Tradjenta (linagliptin) was not statistically significant when compared with placebo. A numerical reduction of 0.34% (P=0.2935) was observed. Results were presented during the International Diabetes Federation World Diabetes Congress 2022.

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

Condition: Diabetes Type 2
Type: drug

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.

Related news and insights