By Ben Glickman

AstraZeneca's diabetes drug Farxiga on Wednesday was approved by U.S. regulators for the treatment of type-2 diabetes in children 10 and older.

Farxiga, which goes by generic name dapagliflozin, was already approved by the U.S. Food and Drug Administration in adults with type-2 diabetes, when used as an adjunct to diet and exercise to improve glycemic control.

The pharmaceutical company said the approval was based on results in a pediatric Phase 3 trial. AstraZeneca said the trial showed a statistically significant improvement in glycemia for children and adolescents with the disease.

Farxiga is already approved for treating pediatric type-2 diabetes patients in 56 countries, including the European Union. The medicine is sold under the brand name Forxiga in the EU.

Write to Ben Glickman at

(END) Dow Jones Newswires

06-12-24 1816ET