AstraZeneca’s FARXIGA® (dapagliflozin) has received approval from the US Food and Drug Administration (FDA) for improving glycemic control in pediatric patients with type-2 diabetes (T2D) aged 10 years and older. This approval follows positive results from the pediatric T2NOW Phase III trial. Previously, FARXIGA was approved in the US for adults with T2D as an adjunct to diet and exercise.
Ruud Dobber, Executive Vice President of AstraZeneca’s BioPharmaceuticals Business Unit, stated: “The prevalence of type-2 diabetes is rising in children and adolescents, yet oral treatment options are limited. This approval marks a significant milestone for pediatric patients in the US, addressing high unmet needs and reinforcing AstraZeneca’s commitment to innovative treatments for cardiovascular, renal, and metabolic diseases.”
Type-2 diabetes is a chronic condition affecting all ages, with increasing incidence in children and adolescents globally. In the US, nearly 30,000 individuals under 20 live with T2D, with 5,300 new cases annually. Younger patients often face earlier onset of complications and faster disease progression compared to adults.
The T2NOW Phase III trial, published in The New England Journal of Medicine Evidence, showed a significant reduction in A1C, a marker of average blood sugar, for patients treated with FARXIGA compared to placebo. The adjusted mean change in A1C was -0.62% for FARXIGA versus +0.41% for placebo, a difference of -1.03% (95% CI: -1.57-0.49; p<0.001). The trial achieved statistical significance in all primary and secondary endpoints at week 26, demonstrating FARXIGA’s clinically meaningful improvements in glycemia for pediatric T2D patients. The safety profile was consistent with that observed in adults.
FARXIGA, a first-in-class, oral, once-daily sodium-glucose cotransporter 2 (SGLT2) inhibitor, is approved in 126 countries, including the EU (marketed as Forxiga), for adults with T2D. It is also approved for pediatric patients aged 10 years and older with T2D in 56 countries based on the T2GO Phase III trial results.
Additional regulatory submissions and rollout plans are under consideration.
INDICATIONS AND LIMITATIONS OF USE for FARXIGA® (dapagliflozin)
FARXIGA is indicated for:
- Improving glycemic control in adults and pediatric patients aged 10 years and older with type-2 diabetes mellitus.
- Reducing the risk of hospitalization for heart failure in adults with type-2 diabetes and cardiovascular disease or multiple risk factors.
- Reducing the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure.
- Reducing the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression.
FARXIGA is not recommended for glycemic control in patients with type-1 diabetes or those with an eGFR less than 45 mL/min/1.73 m². It is also not recommended for chronic kidney disease in patients with polycystic kidney disease or those with a history of immunosuppressive therapy.
DOSING
For glycemic control in adults and pediatric patients aged 10 years and older with T2D, the recommended starting dose is 5 mg orally once daily, which can be increased to 10 mg daily if needed. For other indications in adults, the recommended dose is 10 mg daily.
IMPORTANT SAFETY INFORMATION for FARXIGA® (dapagliflozin) 5 mg and 10 mg
Contraindications: History of serious hypersensitivity reaction to dapagliflozin or any of its excipients.
Warnings and Precautions:
- Ketoacidosis: Increased risk in patients with type-1 diabetes and those with pancreatic disorders. Monitor for signs of ketoacidosis and discontinue if suspected.
- Volume Depletion: May cause symptomatic hypotension or acute kidney injury. Assess volume status and renal function before starting therapy.
- Urosepsis and Pyelonephritis: Increased risk of serious urinary tract infections. Evaluate and treat promptly.
- Hypoglycemia: Increased risk when combined with insulin or insulin secretagogues. Adjust doses as needed.
- Necrotizing Fasciitis: Rare but serious cases reported. Discontinue if suspected and treat promptly.
- Genital Mycotic Infections: Increased risk, monitor and treat appropriately.
Most Common Adverse Reactions (≥5%): Female genital mycotic infections, nasopharyngitis, and urinary tract infections.
Use in Specific Populations:
- Pregnancy: Potential risk to fetus, especially in the second and third trimesters.
- Lactation: Not recommended when breastfeeding.
