AstraZeneca's Farxiga approved in US for paediatric type 2 diabetes
The US Food and Drug Administration (FDA) has approved AstraZeneca's Farxiga (dapagliflozin) for the treatment of type 2 diabetes in paediatric patients aged 10 years and older. The approval follows positive results from the T2NOW Phase III clinical trial.
AstraZeneca announced that its medication Farxiga (dapagliflozin) has received approval from the US Food and Drug Administration (FDA) for improving glycaemic control in paediatric patients aged 10 years and older diagnosed with type 2 diabetes. This marks an expansion of treatment options for a growing population facing limited oral therapies.
The FDA's decision is based on the findings of the T2NOW Phase III clinical trial, published in The New England Journal of Medicine Evidence. The study demonstrated a significant reduction in A1C levels, a key indicator of blood sugar control, in patients treated with Farxiga compared to those who received a placebo.
Type 2 diabetes is increasingly prevalent among children and adolescents globally. In the US alone, nearly 30,000 individuals under 20 years old are living with the condition, and younger patients often experience a faster progression of the disease and earlier onset of complications compared to adults.
Farxiga is a sodium-glucose cotransporter 2 (SGLT2) inhibitor taken orally once daily. It was previously approved in the US for adults with type 2 diabetes as an adjunct to diet and exercise.