28 February 2019 - - The US Food and Drug Administration has approved a label update for Farxiga (dapagliflozin) and Xigduo XR (dapagliflozin and metformin HCl extended-release) expanding use in patients with type 2 diabetes and moderate renal impairment (chronic kidney disease with an estimated glomerular filtration rate [eGFR] of 45-59 mL/min/1.73 m2), Anglo-Swiss drugmaker AstraZeneca said.

Farxiga is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Xigduo XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate.

The updated labels lower the eGFR threshold to 45 mL/min/1.73 m2 from 60 mL/min/1.73 m2, expanding the potential population of patients with T2D and impaired renal function who may benefit from the medicine.

Farxiga and Xigduo XR are not recommended when the eGFR is less than 45 mL/min/1.73 m2 and remains contraindicated in patients with severe renal impairment (eGFR