The Food and Drug Administration (FDA) has approved FARXIGA (dapagliflozin) for pediatric patients with type-2 diabetes (T2D) aged ten years and older. The approval stems from positive results from the T2NOW Phase III trial, which demonstrated a significant reduction in A1C levels (a measure of average blood sugar) in patients treated with FARXIGA compared to placebo.
T2D is a chronic disease that affects individuals of all ages. Its prevalence is rising in children and adolescents, and younger patients often face earlier complications and faster disease progression than adults with the condition.
FARXIGA is a first-in-class SGLT2 inhibitor previously approved in adults with T2D as an adjunct to diet and exercise to improve glycemic control. It has been used in over 126 countries, including the EU (under the brand name Forxiga).
In addition to its adult approval, FARXIGA is now approved for pediatric patients in 56 countries based on the T2GO Phase III clinical trial results. Regulatory submissions and rollout plans are being evaluated for further market authorization.
It is important to note that FARXIGA is not recommended for patients with type-1 diabetes or those with T2D and an eGFR of less than 45 mL/min/1.73 m2.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
