{"id":59522,"date":"2024-06-13T01:04:19","date_gmt":"2024-06-12T23:04:19","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/farxiga-approved-in-the-us-for-the-treatment-of-pediatric-type-2-diabetes\/"},"modified":"2024-06-13T01:04:19","modified_gmt":"2024-06-12T23:04:19","slug":"farxiga-approved-in-the-us-for-the-treatment-of-pediatric-type-2-diabetes","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/farxiga-approved-in-the-us-for-the-treatment-of-pediatric-type-2-diabetes\/","title":{"rendered":"FARXIGA approved in the US for the treatment of pediatric type-2 diabetes"},"content":{"rendered":"
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\nUS patients aged 10 years and older can now benefit from FARXIGA for type-2 diabetes<\/i><\/b><\/p>\n

\nApproval based on results from T2NOW, one of the largest pediatric type-2 diabetes Phase III trials to date<\/b><\/i><\/p>\n

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca\u2019s FARXIGA\u00ae<\/sup> (dapagliflozin) has been approved by the US Food and Drug Administration (FDA) to improve glycemic control in pediatric patients with type-2 diabetes (T2D) aged 10 years and older.1<\/sup> The FDA approval was based on positive results from the pediatric T2NOW Phase III trial.2<\/sup> FARXIGA <\/i>was previously approved in the US in adults with T2D as an adjunct to diet and exercise to improve glycemic control.1<\/sup><\/p>\n

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\nRuud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca, said: \u201cThe prevalence of type-2 diabetes continues to rise in children and adolescents, yet oral treatment options have remained limited for this population. Today\u2019s approval represents an important milestone for pediatric patients living with type-2 diabetes in the US, extending this medicine\u2019s potential benefits to even more patients facing high unmet needs and reinforcing AstraZeneca\u2019s commitment to delivering innovative treatments across cardiovascular, renal and metabolic diseases.\u201d<\/p>\n

\nT2D is a chronic disease affecting people of all ages.3,4<\/sup> The incidence and prevalence of T2D in children and adolescents are increasing globally.5<\/sup> In the US, there are nearly 30,000 patients under 20 living with T2D with 5,300 new cases diagnosed each year, according to the US Centers for Disease Control and Prevention and recent research.6,7<\/sup> Younger patients often experience earlier onset of complications and faster advancement of disease compared to adults with the same condition.8-15<\/sup><\/p>\n

\nData from the T2NOW Phase III trial, published in The New England Journal of Medicine<\/i> Evidence<\/i><\/a>, demonstrated a significant reduction in A1C, a marker of average blood sugar, for patients treated with FARXIGA compared to patients receiving placebo.2,16<\/sup> 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).2<\/sup> Statistical significance was achieved in the primary endpoint and in all secondary endpoints versus placebo at week 26, demonstrating FARXIGA can provide clinically meaningful improvements in glycemia for children and adolescents with T2D.2<\/sup> The safety results in this patient population were consistent with those in adults with T2D, in line with the well-characterised safety profile for <\/i>FARXIGA.2<\/sup><\/p>\n

\nFARXIGA, a first-in-class, oral, once-daily sodium-glucose cotransporter 2 (SGLT2) inhibitor, was approved in 126 countries, including the EU (marketed under the brand name Forxiga<\/i>), as an adjunct to diet and exercise to improve glycaemic control in adults with T2D. FARXIGA is also approved for pediatric 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.17,18<\/sup><\/p>\n

\nAdditional regulatory submissions and rollout plans are under consideration pending further market evaluations.<\/p>\n

\nINDICATIONS AND LIMITATIONS OF USE for FARXIGA\u00ae<\/sup> (dapagliflozin)<\/b><\/p>\n

\nFARXIGA is indicated:<\/p>\n