The US Food and Drug Administration (FDA) has expanded approval of United Kingdom-based AstraZeneca's Farxiga (dapagliflozin) and Xigduo XR (dapagliflozin and metformin HCl extended-release) intended to treat type 2 diabetes and moderate renal impairment, it was reported yesterday.

The expanded product labels have been approved to treat patients with T2D and moderate renal impairment, which is a chronic kidney disease with an estimated glomerular filtration rate [eGFR] of 45-59 mL/min/1.73 m². Farxiga is designated as an adjunct to diet and exercise to improve glycaemic control in adults with type two diabetes mellitus, while Xigduo is designated as an adjunct to diet and exercise to improve glycaemic control in adults with type two diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate. The updated labels decrease the eGFR threshold to 45 mL/min/1.73 m² from 60 mL/min/1.73 m², allowing to expand the application of the treatment to more population.

The updates have been based on the results of Derive phase three study, which included patients with inadequately controlled T2D and an eGFR of 45 to 59 mL/min/1.73m² who secured either Farxiga(dapagliflozin 10mg) or placebo over 24 weeks. The company said that Farxiga (dapagliflozin 10mg) provided statistically significant reductions in HbA1c compared with placebo.