New approval brings Farxiga to children with diabetes in the USA – The Pharma Letter

AstraZenecas (LSE: AZN) Farxiga (dapagliflozin) has received approval from the US Food and Drug Administration to improve glycemic control in children with type-2 diabetes (T2D).

The FDA's decision was based on positive results from the Phase III T2NOW trial.

Previously, Farxiga was approved in the USA for adults with T2D as an adjunct to diet and exercise.

Ruud Dobber, executive vice president of AstraZeneca's biopharmaceuticals business unit,

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New approval brings Farxiga to children with diabetes in the USA - The Pharma Letter