The US Food and Drug Administration (FDA) has granted approval for AstraZeneca's Farxiga (dapagliflozin) for the treatment of paediatric patients aged 10 years and above with type-2 diabetes (T2D)
The approval is a significant milestone, expanding the medication's use to improve glycaemic control in children beyond its previous adult-only indication.
The FDA's decision was based on the randomised, double-blind, placebo-controlled T2NOW Phase III trial.
The study assessed the efficacy and safety of dapagliflozin as an additional treatment for children and adolescents already taking metformin, insulin or both.
Participants were assigned to receive either dapagliflozin, saxagliptin or a placebo.
The trial's primary goal was to observe the change in A1C (haemoglobin) levels after 26 weeks compared to placebo for both dapagliflozin and saxagliptin.
Secondary objectives included monitoring fasting plasma glucose levels and the percentage of patients achieving an A1C level below 7%.
Trial results showed a significant decrease in A1C for patients treated with Farxiga versus those given a placebo.
The adjusted mean change in A1C was -0.62% for Farxiga compared to +0.41% for the placebo group.
Farxiga demonstrated a clinically meaningful improvement in glycaemic control for children and adolescents with T2D.
The asset has also been approved for paediatric patients aged 10 years and above with T2D in 56 countries, based on the T2GO Phase III trial.
Further regulatory submissions and market evaluations are underway to determine additional rollout plans.
In addition to its use in diabetes management, Forxiga is approved in more than 100 countries for treating heart failure across the full ventricular ejection fraction range and chronic kidney disease in adults.
AstraZeneca BioPharmaceuticals Business Unit executive vice-president Ruud Dobber stated: “The prevalence of type-2 diabetes continues to rise in children and adolescents, yet oral treatment options have remained limited for this population.
“The 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.”
The latest development comes after AstraZeneca‘s supplemental new drug application for Tagrisso obtained FDA priority review for unresectable Stage III epidermal growth factor receptor-mutated non-small cell lung cancer after chemoradiotherapy.
