Tuesday, July 16, 2024

Diabetes Treatment Advances: FDA Approves AstraZeneca’s Farxiga for Pediatric T2D

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The U.S. Food and Drug Administration (FDA) has approved AstraZeneca’s Farxiga (dapagliflozin) to improve glycaemic control in pediatric patients aged 10 years and older with type-2 diabetes (T2D). This groundbreaking approval is based on the positive results from the T2NOW Phase III trial, one of the largest pediatric T2D trials conducted to date. Farxiga was previously approved for use in adults with T2D as an adjunct to diet and exercise to improve glycaemic control, significantly enhancing patient outcomes.

Ruud Dobber, Executive Vice President of AstraZeneca’s BioPharmaceuticals Business Unit, highlighted the significance of this FDA approval, noting the rising prevalence of type-2 diabetes among children and adolescents. Despite this increase, oral treatment options have remained limited for this young population. This approval represents a significant milestone, offering new treatment possibilities for pediatric patients who face high unmet medical needs and reinforcing AstraZeneca’s commitment to delivering innovative treatments across cardiovascular, renal, and metabolic diseases.

Rising Type-2 Diabetes in Youth: Farxiga Shows Promising Results in Phase III Trial

Type-2 diabetes is a chronic disease that affects individuals of all ages, characterized by elevated glucose levels or hyperglycemia. The incidence and prevalence of T2D in children and adolescents are increasing globally at an alarming rate. In the US alone, nearly 30,000 patients under the age of 20 live with type-2 diabetes, with 5,300 new cases diagnosed each year. Younger patients often experience an earlier onset of complications and faster progression of the disease compared to adults, making effective treatment options crucial for this age group.

The T2NOW Phase III trial, published in The New England Journal of Medicine Evidence, demonstrated significant improvements in A1C levels—a marker of average blood sugar—for patients treated with Farxiga compared to those receiving a 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 safety profile for pediatric patients was consistent with that observed in adults, reaffirming Farxiga’s well-characterized safety and efficacy.


Farxiga Approved for Pediatric Type-2 Diabetes, Expanding AstraZeneca’s Global Reach

Farxiga is a first-in-class, oral, once-daily sodium-glucose cotransporter 2 (SGLT2) inhibitor. It is approved in 126 countries, including the EU, for improving glycemic control in adults with type-2 diabetes. Furthermore, Forxiga, as it is marketed in other regions, is approved for pediatric patients aged 10 years and above in 56 countries. The approval was based on the robust results from the T2GO Phase III clinical trial. Additional regulatory submissions and rollout plans are under consideration as AstraZeneca continues to evaluate further market needs and opportunities.

AstraZeneca’s Cardiovascular, Renal, and Metabolism (CVRM) unit is a key growth driver for the company. The approval of Farxiga for pediatric type-2 diabetes patients underscores AstraZeneca’s dedication to providing innovative treatments across CVRM diseases. By following the science to understand the underlying links between the heart, kidneys, liver, and pancreas, AstraZeneca is investing in a portfolio of medicines aimed at organ protection. Their goal is to slow or stop disease progression, ultimately paving the way toward regenerative therapies and improving the lives of millions through early detection, diagnosis, and treatment of interconnected diseases.


Resource: AstraZeneca, June 12, 2024

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