FDA Approves Dapagliflozin to Treat Pediatric Patients with Type 2 Diabetes


The therapy from AstraZeneca is indicated to improve glycemic control in patients aged 10 years or older.

The FDA approved dapagliflozin (Farxiga) to improve glycemic control in pediatric patients aged 10 years or older with type 2 diabetes (T2D), AstraZeneca announced in a release. The therapy, which is an oral, once-daily sodium-glucose cotransporter 2 (SGLT2) inhibitor, was previously approved for adults with T2D as an adjunct to diet and exercise.1

FDA Approves Dapagliflozin to Treat Pediatric Patients with Type 2 Diabetes / JHVEPhoto - stock.adobe.com

FDA Approves Dapagliflozin to Treat Pediatric Patients with Type 2 Diabetes / JHVEPhoto - stock.adobe.com

The approval was based on data from the T2NOW trial (NCT01042977), in which the therapy demonstrated a significant reduction in A1c levels in pediatric patients with T2D compared to placebo and a safety profile consistent with data seen in adult patient populations. The study results were published in The New England Journal of Medicine.2

About T2NOW

Trial Name: Efficacy and Safety in Patients With Type 2 Diabetes Mellitus and Cardiovascular Disease

ClinicalTrials.gov Identifier: NCT01042977

Sponsor: AstraZeneca

Summary: This study is carried out to assess whether dapagliflozin improves glycemic control, decreases fasting plasma glucose levels, body weight and blood pressure when added to patient's existing medications and how it compares with their usual treatment without added dapagliflozin. Safety data will be collected and analysed to confirm that treatment with dapagliflozin is safe and well tolerated in patients who have diabetes and cardiovascular disease.

T2NOW was a randomized, double-blind, placebo-controlled phase 2 trial to evaluate the efficacy and safety of dapagliflozin as add-on treatment in children and adolescents with T2D receiving metformin, insulin or both. The study cohort included 245 patients with T2D between the ages of 10 and 17. Patients were assigned randomly to receive either 5 mg of dapagliflozin, 2.5 mg of saxagliptin, or placebo.

READ MORE: GLP-1s May Lower Risk of Acute Pancreatitis in Patients with T2D, Obesity

The primary study endpoint was change in A1c at week 26. Secondary endpoints included change in fasting plasma glucose and proportion of patients who achieved an A1c less than 7% after 26 weeks. The safety of dapagliflozin was assessed over 52 weeks.

Investigators found that the adjusted mean change in A1C compared to placebo was −1.03 for dapagliflozin and −0.44 for saxagliptin. Over the 52 week safety assessment, most adverse events were mild, with the most common being headache. Adverse and serious adverse events occurred in 72.8% and 8.6% of patients who received dapagliflozin, respectively. Additionally, 4.9% of patients who received the therapy experienced severe hypoglycemia.

In the release, AstraZeneca said that a rollout plan for dapagliflozin was currently under consideration “pending further market evaluation.”

“The prevalence of type-2 diabetes continues to rise in children and adolescents, yet oral treatment options have remained limited for this population,” Ruud Dobber, executive vice president of the Biopharmaceuticals Business Unit at AstraZeneca, said in a release.1 “Today’s approval represents an important milestone for pediatric 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.”

READ MORE: Diabetes Resource Center

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1. FARXIGA approved in the US for the treatment of pediatric type-2 diabetes. News Release. AstraZeneca. June 12, 2024. Accessed June 13, 2024. https://www.astrazeneca-us.com/media/press-releases/2024/farxiga-approved-in-the-us-for-the-treatment-of-pediatric-type-two-diabetes.html
2. Shehadeh N, Barrett T, Galassetti P, et al. Dapagliflozin or Saxagliptin in Pediatric Type 2 Diabetes. NEJM Evid. 2023 Dec;2(12):EVIDoa2300210. doi: 10.1056/EVIDoa2300210. Epub 2023 Oct 4. PMID: 38320500.
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