AstraZeneca’s oral SGLT2 inhibitor Farxiga (dapagliflozin) has been approved by the US Food and Drug Administration (FDA) to improve glycaemic control in type 2 diabetes (T2D) patients aged ten years and older.
T2D accounts for the majority of diabetes cases and its global prevalence in children and adolescents is increasing, affecting nearly 30,000 people aged under 20 years in the US alone.
Younger patients often experience earlier onset of complications and faster advancement of disease compared to adults, AZ outlined.
The FDA’s approval was supported by positive results from the late-stage T2NOW trial, which assessed the efficacy and safety of Farxiga as an add-on treatment in children and adolescents with T2D receiving metformin, insulin or both.
Statistical significance was seen in the primary endpoint and all secondary endpoints versus placebo at week 26, which AZ said establishes that Farxiga can “provide clinically meaningful improvements in glycaemia” for this patient population.
Farxiga was associated with a significant reduction in A1C, a marker of average blood sugar, compared with placebo after 26 weeks, and safety results from the study were reported to be consistent with those in adults with T2D.
Farxiga, also marketed under the brand name Forxiga, is approved in more than 120 countries as an adjunct to diet and exercise to improve glycaemic control in adults with T2D.
The drug is also approved in certain markets, including the EU, for paediatric patients aged ten years and older with T2D.
Commenting on the latest authorisation, Ruud Dobber, executive vice president, biopharmaceuticals business unit, AstraZeneca, said: “The prevalence of T2D continues to rise in children and adolescents, yet oral treatment options have remained limited for this population.
“[The] approval represents an important milestone for paediatric patients living with T2D in the US, extending this medicine’s potential benefits to even more patients facing high unmet needs.…”
The approval comes less than two weeks after AZ’s Tagrisso (osimertinib) was recommended by the European Medicines Agency’s human medicines committee as part of a combination treatment for a subset of advanced non-small cell lung cancer patients.