FDA approves dapagliflozin for children and adolescents with type 2 diabetes
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Key takeaways:
- Dapagliflozin was approved by FDA for children and adolescents aged 10 years and older with type 2 diabetes.
- The SGLT2 inhibitor lowered HbA1c by 0.62 percentage points at 26 weeks in the T2NOW trial.
The FDA approved the SGLT2 inhibitor dapagliflozin to improve glycemic control among children and adolescents aged 10 years and older with type 2 diabetes, according to an industry press release.
Dapagliflozin (Farxiga, AstraZeneca) received approval based on findings from the T2NOW phase 3 trial. In the trial, children and adolescents with type 2 diabetes receiving metformin, insulin or both were randomly assigned to 5 mg or 10 mg dapagliflozin, 2.5 mg or 5 mg saxagliptin, or placebo as an add-on treatment for 26 weeks. The primary endpoint was change in HbA1c.
At 26 weeks, the dapagliflozin group had a 0.62 percentage point reduction in HbA1c compared with an 0.41 percentage point increase for the placebo group (P < .001). Safety results in the study were consistent with those observed among adults with type 2 diabetes.
“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 of AstraZeneca, said in the release. “Today’s approval represents an important milestone for pediatric patients living with type 2 diabetes in the U.S., 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.”
Dapagliflozin was approved by the FDA in 2013 for adults with type 2 diabetes as an adjunct to diet and exercise to improve glycemic control. As Healio previously reported, the medication has since been approved for all people with heart failure and adults with chronic kidney disease.
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