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Government Health Agency News

FDA

Dapagliflozin OK'd for treatment of type 2 diabetes in children

June 17, 2024

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FDA expanded the approval of dapagliflozin (Farxiga) as an adjunct to diet and exercise to improve glycemic control in pediatric patients ≥10 years of age with type 2 diabetes. Approval for the expanded indication was based on data from the phase 3 T2NOW trial (N=157) in which patients ages 10 to 17 years of age with type 2 diabetes treated with dapagliflozin experienced significant improvements in HbA1c and fasting glucose compared with placebo.

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