Eli Lilly and Boehringer Ingelheim’s supplemental New Drug Application (sNDA) for the use of Jardiance (empagliflozin) in children aged ten years and older with type 2 diabetes has been accepted by the US Food and Drug Administration (FDA).
Initially approved in 2014, Jardiance is a once-daily tablet used alongside diet and exercise to lower blood sugar in adults with type 2 diabetes. The drug, however, is not currently indicated for children.
Type 2 diabetes most often develops in people over the age of 45, but more children, teenagers and young adults are developing the condition, according to the Centers for Disease Control and Prevention.
“There are clear unmet needs for young people living with type 2 diabetes, which has nearly doubled in prevalence in people aged ten to 19 over the past two decades,” said Mohamed Eid, vice president, clinical development and medical affairs, cardio-renal-metabolism and respiratory medicine, Boehringer Ingelheim Pharmaceuticals.
The companies explained that, if the sNDA is approved, Jardiance would become the first SGLT2 inhibitor indicated for this population in the US.
The application is supported by results from the phase 3 DINAMO trial, in which Jardiance was associated with a significant reduction in A1c – a marker of average blood sugar – versus placebo in patients aged between ten and 17.
When added to other baseline treatments, such as diet, exercise, metformin and/or insulin, Jardiance 10mg and 25mg pooled doses reduced A1c by 0.84% compared with placebo at week 26, the companies reported.
Commenting further on the significance of the application, Jeff Emmick, vice president, product development at Eli Lilly, said: “Impacting an estimated 39,000 people under the age of 20, type 2 diabetes is a growing health issue for young people in the US.
“If approved, Jardiance would be a new oral treatment option for type 2 diabetes in children ten years and older in the US, making this application acceptance an important step forward as we add to the body of knowledge for this vulnerable patient population, for whom oral treatment options have been limited.”