Farxiga Approved for Type 2 Diabetes in Children

Farxiga (dapagliflozin) has been approved by the FDA to treat type-2 diabetes patients ages 10 and older, AstraZeneca announced yesterday in a press release. The recommended dose is a 5mg or 10mg tablet taken daily, which costs about $622 for a month’s supply.

This approval is based on the results from the T2NOW phase 3 trial published in The New England Journal of Medicine Evidence last October. The trial was one of the largest ever phase 3 trials for pediatric type 2 diabetes. It tested the effectiveness of Farxiga and saxagliptin, another diabetic drug, on participants ages 10 to 17. Researchers found that Farxiga was nearly twice as good at reducing A1C levels than saxagliptin. The most reported adverse effect of Farxiga was a nonserious headache in 14.8% of participants. Severe hypoglycemia only occurred in 4.9% of patients on Farxiga.

Type 2 diabetes is a chronic condition where a patient’s pancreas stops making enough insulin, which is a hormone that controls glucose levels. A buildup of too much glucose in the body can be deadly. Type 2 diabetes has genetic components but is often associated with being overweight. It affects all age groups, but rates in children and adolescents have been growing globally every year. Children who are diagnosed often have a faster onset of symptoms.

“The prevalence of type 2 diabetes continues to rise in children and adolescents, yet oral treatment options have remained limited for this population,” Ruud Dobber, executive vice president, BioPharmaceuticals Business Unit, AstraZeneca, said in the press release.

Currently, there are about 30,000 patients in the United States with type 2 diabetes under the age of 20, with an additional 5,300 diagnosed every year, the U.S. Centers for Disease Control and Prevention reports.

Farxiga (marketed as Forxiga outside of the United States) has been approved in 126 countries for patients with type-2 diabetes.

Forxiga is also approved to treat heart failure in 100 countries and was the first heart failure medication to save the lives of patients across the full ejection fraction range.