AstraZeneca's Farxiga Bags US FDA Nod For Type-2 Diabetes

The US Food and Drug Administration (FDA) has approved AstraZeneca's Farxiga (dapagliflozin) for improving glycaemic control in children with type-2 diabetes (T2D) aged 10 and older. The positive outcomes of the paediatric T2NOW phase III trial were the foundation for the FDA's approval. In the past, the US FDA approved Farxiga for adults with T2D as an adjunct to diet and exercise to control blood sugar levels.

Ruud Dobber, executive vice president, biopharmaceuticals business unit, AstraZeneca, said: “The prevalence of type-2 diabetes continues to rise in children and adolescents, yet oral treatment options have remained limited for this population. Today’s approval represents an important milestone for paediatric patients living with type-2 diabetes in the US, extending this medicine’s potential benefits to even more patients facing high unmet needs and reinforcing AstraZeneca’s commitment to delivering innovative treatments across cardiovascular, renal and metabolic diseases.”

T2D is a long-term condition that affects people of all ages. T2D is becoming more common in children and adolescents around the world. According to the US Centers for Disease Control and Prevention and recent research, 5,300 new cases of T2D are diagnosed each year, affecting nearly 30,000 patients under the age of 20. When compared to adults with the same condition, younger patients frequently experience earlier onset of complications and faster disease progression.