AstraZeneca has received the US Food and Drug Administration (FDA) approval for Farxiga (dapagliflozin) to treat type-2 diabetes (T2D) in paediatric patients aged 10 years and above.
Farxiga is an oral, once-daily sodium-glucose cotransporter 2 (SGLT2) inhibitor, previously approved in 126 countries, as an adjunct to diet and exercise to treat adults with T2D.
It is also approved in 56 countries, to treat paediatric patients aged 10 years and above with T2D, including the EU and other regions, based on results from Phase 3 T2GO clinical trial.
AstraZeneca biopharmaceuticals business unit executive vice president Ruud Dobber said: “The prevalence of type-2 diabetes continues to rise in children and adolescents, yet oral treatment options have remained limited for this population.
Today’s approval represents an important milestone for paediatric patients living with type-2 diabetes in the US, extending this medicine’s potential benefits to even more patients facing high unmet needs and reinforcing AstraZeneca’s commitment to delivering innovative treatments across cardiovascular, renal and metabolic diseases.”
T2D is a chronic disease characterised by pathophysiologic defects leading to elevated glucose levels, or hyperglycaemia, which contributes to further progression of the disease.
It is the most common type of diabetes, accounting for over 90% of all diabetes worldwide, with increasing incidence and prevalence rates in children and adolescents.
The younger patients often experience earlier onset of complications and faster advancement of disease compared to adults with the same condition, said the British drugmaker.
The FDA approval of Farxiga in the new indication was supported by positive results from the paediatric Phase 3 T2NOW trial.
Data from the study showed a significant reduction in A1C, a marker of average blood sugar, for patients treated with Farxiga compared to patients receiving placebo.
In the study, the drug achieved statistical significance in the primary endpoint and all secondary endpoints, compared to placebo, at week 26.
Furthermore, Farxiga showed a safety profile in this patient population that was consistent with those in adults with T2D, in line with the well-characterised safety profile for the drug.
