AstraZeneca’s Farxiga approved by FDA to treat pediatric diabetes

AstraZeneca’s Farxiga has been approved by the US Food and Drug Administration to improve glycaemic control in paediatric patients with type-2 diabetes aged 10 years and older. The FDA approval was based on positive results from the paediatric T2NOW Phase III trial. Farxiga was previously approved in the US in adults with T2D as an adjunct to diet and exercise to improve glycaemic control. 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.”