An Important milestone for paediatric patients living with type-2 Diabetes
Farxiga (Dapagliflozin) now approved in US for paediatric patients with type 2 diabetes aged 10 years and older
USFDA approved AstraZeneca’s Farxiga to improve glycaemic control in paediatric patients with type-2 diabetes aged 10 years and older. The approval was based on the positive results from the T2NOW Phase III trial.
Farxiga, a first-in-class, oral, once-daily sodium-glucose cotransporter 2 (SGLT2) inhibitor, was already approved in US to improve glycaemic control in adults with type-2 diabetes as an adjunct to diet and exercise. Farxiga is also approved for paediatric patients aged 10 years and above with T2D in 56 countries, including the EU and other regions, based on results from the T2GO Phase III clinical trial.
The T2NOW study result showed a significant reduction in A1C in the Farxiga group compared to placebo group. Adjusted mean changes in A1C were -0.62% in Farxiga compared to that of +0.41% in placebo. At week 26, statistical significance was achieved in primary endpoint and all secondary endpoints compared to placebo. This indicates that Farxiga can clinically improve glycaemia in children and adolescents living with T2D. The safety results in this paediatric patient population were consistent with those in adults with T2D and in line with the safety profile for Farxiga.
As per IDF 2021 report, approx. 537 million adults (20-79 Years) are living with diabetes worldwide. In the MENA region, there were 73 million adults reported with diabetes in 2021 which is predicted to increase by 87% in 2045 (136 million). This indicates a need for awareness and better management of diabetes.
The Farxiga approval marks an achievement for AstraZeneca by extending the potential benefit to paediatric patients facing unmet medical needs.
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