AstraZeneca's Farxiga (Dapagliflozin) Receives FDA Approval for Treatment of Pediatric Type 2 Diabetes in Patients Aged 10 and Older

Jun 13, 2024 07:45 CST Updated 07:46

AstraZeneca

Biopharmaceutical Manufacturer

June 12,AstraZenecaFarxiga (Dapagliflozin) has been approved by the U.S. FDA for improving blood sugar control in children aged 10 years and older with type 2 diabetes (T2D). Farxiga was previously approved in the United States for adult patients as an adjunct to diet and exercise to improve blood sugar control.

The FDA approval is based onPhase IIIPositive results from the T2NOW trial,The T2NOW study is a 26-week randomized, double-blind, multicenter Phase III clinical trial designed to evaluate the acceptance ofMetformin、InsulinEfficacy and Safety of Dapagliflozin as Add-on Therapy in Children and Adolescents with Type 2 Diabetes Treated with One or Both.

The study enrolled a total of 245 patients, who were randomly assigned to receive either 5mg of dapagliflozin (n=81) or 2.5mg.Saxagliptin(saxagliptin, n=88) and placebo (n=76) treatment. At week 12, patients with HbA1c ≥7% in the dapagliflozin and saxagliptin groups were further randomized in a 1:1 ratio to either continue dosing or increase to a higher dose (10mg dapagliflozin or 5mg saxagliptin).

The primary endpoint was the change in HbA1c at week 26, with secondary endpoints including the change in fasting plasma glucose (FPG) and the proportion of patients achieving HbA1c <7.0% (53 mmol/mol) at week 26. Safety was assessed over 52 weeks.

The results showed that, for the primary endpoint, at Week 26, the adjusted mean reduction in HbA1c was 0.62% in the dapagliflozin group, while the placebo group increased by 0.41%, with a difference of 1.03%; in the saxagliptin group, the adjusted mean increase in HbA1c was 0.06%, compared to a 0.5% increase in the placebo group, with a difference of 0.44%. Other secondary endpoints also showed statistically significant improvements.

Primary and Secondary Endpoints(Source: The New England Journal of Medicine)

In terms of safety, the safety of dapagliflozin in pediatric and adolescent patients with type 2 diabetes is consistent with that in adult patients.

T2D is a chronic disease that affects people of all ages. Globally, the incidence and prevalence of T2D among children and adolescents are on the rise. According to the U.S. Centers for Disease Control and Prevention and recent studies, in the United States, there are nearly 30,000 T2D patients under the age of 20, with 5,300 new diagnosed cases each year. Compared with adults, younger patients tend to experience earlier complications and faster disease progression.

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