AstraZeneca's Farxiga Approved For Treating Pediatric Type-2 Diabetes in U.S.
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
June 12, 2024 18:16 ET (22:16 GMT)
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