Jardiance is first SGLT2 given FDA OK for use in children

With rates of juvenile type 2 diabetes rocketing in the US, doctors now have access to an alternative oral therapy – the first new oral option for more than 20 years.

Eli Lilly and Boehringer Ingelheim’s Jardiance (empagliflozin) and related product Synjardy (empagliflozin and metformin) have been cleared by the FDA for use in children aged 10 years and over with type 2 diabetes in combination with diet and exercise.

Previously, the only oral therapy available for these children was metformin, although a couple of injectable therapies have been approved, including Novo Nordisk’s Victoza (liraglutide) and AstraZeneca’s Bydureon (exenatide).

According to the FDA, the incidence of type 2 diabetes in children increased by 4.8% per year from 2002 to 2015, with an estimated 28,000 cases in 2017 that it predicts could reach 220,000 by 2060 – mostly in minority racial and ethnic groups – if nothing is done to tackle the issue. The driving force behind the trend is thought to be rising levels of childhood obesity.

According to Lilly and Boehringer, there are around 5,700 new cases of type 2 diabetes in the over-10 paediatric population each year in the US.

The two companies carried out a phase 3 trial called DINAMO to support the new indication, which enrolled 157 patients aged 10 to 17 years with inadequately controlled type 2 diabetes who were randomised to treatment with either empagliflozin, a DPP-4 inhibitor (linagliptin), or placebo, given on top of metformin and in some cases insulin.

The study found that, after 26 weeks, treatment with empagliflozin was superior in reducing haemoglobin A1c levels – a measure of average blood sugar over time – compared to placebo, with a statistically significant 0.8% difference between the groups.

Common side effects in children treated with empagliflozin were generally similar to those reported in adults, except there was a higher risk of hypoglycaemia - low blood sugar levels - compared to placebo.

“Compared to adults, children with type 2 diabetes have limited treatment options, even though the disease and symptom onset generally progresses more rapidly in children,” said Michelle Carey of the FDA’s division of diabetes, lipid disorders, and obesity. “Today’s approvals provide much-needed additional treatment options for children with type 2 diabetes.”

Jardiance has been approved for use in adults with type 2 diabetes since 2014 and is also used to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease, and to reduce the risk of cardiovascular death and hospitalisation for heart failure in adults with heart failure. The FDA is currently reviewing the use of the drug to treat people with chronic kidney disease, with a decision due later this year.