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 ben.glickman@wsj.com

(END) Dow Jones Newswires

06-12-24 1816ET