FDA Approves AstraZeneca's Farxiga For Pediatric Use In Type-2 Diabetes

(RTTNews) - The US Food and Drug Administration AstraZeneca's Farxiga (dapagliflozin) to improve glycemic control in pediatric patients with type-2 diabetes or T2D aged 10 years and older.

The FDA approval was based on positive results from the pediatric T2NOW Phase III trial. Farxiga was previously approved in the US in adults with type-2 diabetes as an adjunct to diet and exercise to improve glycemic control.

Farxiga, a first-in-class, oral, once-daily sodium-glucose cotransporter 2 (SGLT2) inhibitor, was approved in 126 countries, including the EU (marketed under the brand name Forxiga), as an adjunct to diet and exercise to improve glycaemic control in adults with T2D.

Farxiga is also approved for pediatric patients aged 10 years and above with T2D in 56 countries, including the EU and other regions, based on results from the T2GO Phase III clinical trial.

Additional regulatory submissions and rollout plans are under consideration pending further market evaluations.

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