The Food and Drug Administration (FDA) has approved updated labeling for Farxiga (dapagliflozin; AstraZeneca) and Xigduo XR (dapagliflozin and metformin HCl extended-release; AstraZeneca) to expand the use of these products in type 2 diabetes patients with moderate renal impairment.
The updated labeling for these products now states that no dosage adjustment is needed in patients with eGFR ≥45mL/min/1.73m2; use of Farxiga and Xigduo XR is not recommended in patients with eGFR <45mL/min/1.73m2 and remains contraindicated in those with eGFR <30mL/min/1.73m2.
The approval was based on data from the DERIVE phase 3 study which included patients with inadequately controlled T2D and an eGFR of 45–59mL/min/1.73m2. Patients were randomized to receive dapagliflozin 10mg or placebo for 24 weeks; the primary endpoint of the study was adjusted mean change from baseline in hemoglobin A1c (HbA1c).
Results showed that treatment with dapagliflozin led to statistically significant reductions in HbA1c compared with placebo. With regard to safety, while a reduction in eGFR was noted in the dapagliflozin arm, eGFR generally returned toward baseline after treatment discontinuation.
Dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, reduces reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.
Farxiga is indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D. Xigduo XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D when treatment with both dapagliflozin and metformin is appropriate.
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