The approval was based on the findings from the DINAMO Phase 3 trial of patients aged 10-17 years with type 2 diabetes in which Jardiance showed a statistically significant reduction in the primary endpoint
FDA approves Jardiance for type 2 diabetes in children. (Credit: Christina Victoria Craft on Unsplash)
Eli Lilly and its partner Boehringer Ingelheim announced that the US Food and Drug Administration (FDA) has cleared their Jardiance (empagliflozin) to treat type 2 diabetes in children.
Jardiance 10mg and 25mg tablets were approved to lower blood sugar in addition to diet and exercise in type 2 diabetes children aged 10 years and older.
Empagliflozin works by enhancing the excretion of glucose in urine. It is said to be the first and only SGLT2 inhibitor approved for this patient population.
The approval was based on the findings from the DINAMO Phase 3 trial of patients aged 10-17 years with type 2 diabetes.
As per the results, the Jardiance drug showed a statistically significant reduction in the primary endpoint of change from baseline in A1c at 26 weeks compared with the placebo.
Lilly said that Jardiance 10mg and 25mg pooled doses when added to other baseline treatments, reduced A1c by 0.8% compared with placebo at week 26.
Additionally, the safety profile of paediatric patients treated with diabetes drugs was like that observed in adults with type 2 diabetes, except for hypoglycemia risk.
Lilly Diabetes & Obesity Global Medical Affairs SVP Leonard Glass said: “With this latest FDA decision, Jardiance is now approved to lower A1c along with diet and exercise in children 10 years and older with type 2 diabetes.
“This decision brings us one step closer in our efforts to improve outcomes for this population and supports our larger commitment to advance treatment options for people living with a range of cardiometabolic conditions.”
DINAMO is a multicentre, randomised, double-blind, parallel-group Phase 3 trial. It recruited 262 patients with type 2 diabetes previously treated with metformin or insulin. The primary endpoint was defined as the change from baseline in A1c at 26 weeks.
Boehringer Ingelheim Medicine & Regulatory Affairs SVP Lennart Jungersten said: “As the burden of type 2 diabetes increases among young people, so does the need for additional treatment options with proven clinical benefits.
“This FDA approval, which is based on the efficacy results and safety data from the DINAMO trial, marks an important milestone in helping address a clear unmet need for oral treatment options, in addition to metformin, to lower A1c in this rapidly rising population.”