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FDA Approves Xigduo XR (dapagliflozin/metformin) for Glycemic Control in Children Aged 10 Years and Older with Type-2 Diabetes

12 June 2024 – AstraZeneca’s Xigduo XR (dapagliflozin/metformin) has been approved by the US Food and Drug Administration (FDA) to improve glycaemic control in pediatric patients with type-2 diabetes (T2D) aged 10 years and older. The FDA approval was based on positive results from the pediatric T2NOW Phase III trial. Xigduo XR was previously approved in the US in adults with T2D as an adjunct to diet and exercise to improve glycemic control.

Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca, said: “The prevalence of type-2 diabetes continues to rise in children and adolescents, yet oral treatment options have remained limited for this population. Today’s approval represents an important milestone for paediatric patients living with type-2 diabetes in the US, extending this medicine’s potential benefits to even more patients facing high unmet needs and reinforcing AstraZeneca’s commitment to delivering innovative treatments across cardiovascular, renal, and metabolic diseases.”

T2D is a chronic disease affecting people of all ages. The incidence and prevalence of T2D in children and adolescents are increasing globally.5 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 Younger patients often experience earlier onset of complications and faster advancement of disease compared to adults with the same condition.

Data from the T2NOW Phase III trial, published in The New England Journal of Medicine Evidence, demonstrated a significant reduction in A1C, a marker of average blood sugar, for patients treated with dapagliflozin compared to patients receiving placebo. Adjusted mean change in A1C was -0.62% for dapagliflozin versus +0.41% for placebo, a difference of -1.03% (95% CI: -1.57-0.49; p<0.001).2 Statistical significance was achieved in the primary endpoint and in all secondary endpoints versus placebo at week 26, demonstrating dapagliflozin can provide clinically meaningful improvements in glycemia for children and adolescents with T2D.2 The safety results in this patient population were consistent with those in adults with T2D, in line with the well-characterized safety profile for dapagliflozin.

About T2D

T2D is a chronic disease characterized by pathophysiologic defects leading to elevated glucose levels, or hyperglycemia. Over time, this sustained hyperglycemia contributes to the further progression of the disease. The prevalence of diabetes is projected to reach 783 million by 2045. T2D is the most common type of diabetes, accounting for over 90% of all diabetes worldwide. Significant unmet medical need still exists, as many patients have poor blood sugar control and low medication adherence.

About T2NOW

T2NOW was a randomized, double-blind, placebo-controlled Phase III trial designed to evaluate the efficacy and safety of dapagliflozin as an add-on treatment in children and adolescents with T2D receiving metformin, insulin or both. Patients were randomized to dapagliflozin, saxagliptin or placebo. Those receiving an active drug were further randomized to continue their current dose or up-titrate to a higher dose of the same active treatment. The primary endpoint was a change in A1C after 26 weeks vs placebo for dapagliflozin (5 or 10 mg) or saxagliptin (2.5 or 5 mg). Secondary endpoints included change in fasting plasma glucose and proportion of patients (A1C ≥7% at baseline) achieving A1C <7.0% (53 mmol/mol) after 26 weeks.

About Xigduo XR

Xigduo XR (dapagliflozin/metformin) is an extended-release tablet containing a combination of dapagliflozin and metformin. Dapagliflozin and metformin are oral diabetes medicines that help control blood sugar levels. Dapagliflozin works by helping the kidneys get rid of glucose from your bloodstream. Metformin lowers glucose production in the liver and also causes your intestines to absorb less glucose. It was first FDA-approved on October 29, 2014.

Source: AstraZeneca Press Release

Posted: June 2024

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