FARXIGA Approved in US for Pediatric Type-2 Diabetes

The US Food and Drug Administration (FDA) has recently approved AstraZeneca's FARXIGA® (dapagliflozin) for use in managing glycemic control in pediatric patients aged 10 years and older with type-2 diabetes (T2D). This approval was based on positive results from the T2NOW Phase III clinical trial, which is one of the most extensive pediatric trials for T2D to date. This new authorization extends the use of FARXIGA, which was already approved for adult patients with T2D, to a younger demographic, addressing a significant gap in treatment options for children and adolescents with the condition.

Ruud Dobber, Executive Vice President of AstraZeneca's BioPharmaceuticals Business Unit, emphasized the growing prevalence of T2D among younger populations and highlighted the limited oral treatment options available for them. He described the FDA's approval as a crucial development for pediatric T2D patients in the US, reinforcing AstraZeneca's dedication to providing innovative treatments for cardiovascular, renal, and metabolic diseases.

Type-2 diabetes is a chronic condition that affects individuals of all ages. The incidence and prevalence of T2D are rising globally, particularly among children and adolescents. In the US alone, nearly 30,000 individuals under 20 are living with T2D, with an estimated 5,300 new cases diagnosed annually. Younger patients with T2D often face a quicker onset of complications and more rapid disease progression compared to adults.

The T2NOW Phase III trial demonstrated significant efficacy of FARXIGA in reducing A1C, a marker of average blood sugar levels, compared to placebo. The trial results indicated an adjusted mean change in A1C of -0.62% for patients treated with FARXIGA versus +0.41% for those on placebo, a difference of -1.03%. These results were statistically significant and showed meaningful improvements in glycemic control for the pediatric population. The safety profile of FARXIGA in children was consistent with that observed in adults.

FARXIGA is a first-in-class, oral, once-daily sodium-glucose cotransporter 2 (SGLT2) inhibitor. It has been approved in 126 countries, including in the European Union under the brand name Forxiga, as an adjunct to diet and exercise for improving glycemic control in adults with T2D. FARXIGA is also approved for pediatric use in 56 countries, including the EU, based on the T2GO Phase III trial results.

In addition to its use for T2D, FARXIGA has been approved for reducing the risk of hospitalization due to heart failure in adults with T2D and established cardiovascular disease or multiple cardiovascular risk factors. It is also approved to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure and to reduce the risk of sustained decline in kidney function, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease.

The recommended starting dose of FARXIGA for improving glycemic control in adults and pediatric patients aged 10 years and older with T2D is 5 mg once daily, which can be increased to 10 mg for additional glycemic control. For other indications in adults, the recommended dose is 10 mg once daily.

The safety information for FARXIGA includes warnings about the increased risk of diabetic ketoacidosis in patients with type-1 diabetes mellitus, volume depletion, urinary tract infections, hypoglycemia when coadministered with insulin, necrotizing fasciitis of the perineum, and genital mycotic infections. It is also noted that FARXIGA is not recommended for use in pregnant or breastfeeding women.

With the FDA's recent approval, FARXIGA now offers a new treatment option for pediatric patients with type-2 diabetes, addressing a critical unmet need in this growing patient population.