Eli Lilly and Boehringer Ingelheim have received approval from the US Food and Drug Administration (FDA) for Jardiance (empagliflozin) 10mg and 25mg tablets to treat type 2 diabetes in children aged 10 years and above.
The tablets are intended to reduce blood sugar, along with modification of diet and exercise in these patients.
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Jardiance is a prescription medicine that helps lower the risk of hospitalisation and cardiovascular death for adults with heart failure.
It also helps decrease the risk of cardiovascular death in adults with type 2 diabetes.
Lilly diabetes and obesity global medical affairs senior vice-president Leonard Glass stated: “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.”
The US regulator has approved the therapy based on data from the DINAMO Phase III study, which showed that Jardiance significantly reduced haemoglobin A1c, a blood test determining average blood sugar levels over the previous three months, compared to placebo.
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By GlobalDataThe double-blind, parallel group, randomised and multicentre study recruited participants aged 10-17 years with type 2 diabetes previously treated with insulin or metformin.
Change from baseline in A1c at 26 weeks was the primary endpoint of the study.
Boehringer Ingelheim medicine and regulatory affairs senior vice-president Lennart Jungersten stated: “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.”
