FDA Approves Farxiga (dapagliflozin) for Chronic Kidney Disease and Heart Failure
The FDA has approved Farxiga (dapagliflozin) for two new indications: to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression, and to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure. The drug, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, was previously approved for glycemic control in type 2 diabetes and for reducing heart failure hospitalization in diabetic patients with cardiovascular disease. The new approvals expand the drug's utility to broader populations, including those without diabetes. Clinicians should note that Farxiga is not recommended for chronic kidney disease in patients with polycystic kidney disease or those requiring immunosuppressive therapy, and it should not be used for glycemic control in type 1 diabetes or in type 2 diabetes with eGFR below 45 mL/min/1.73 m².
＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Farxiga (dapagliflozin) is a sodium-glucose cotransporter 2 (SGLT2) inhibitor. It inhibits SGLT2 in the proximal renal tubule, reducing glucose reabsorption and increasing urinary glucose excretion. The mechanisms for cardiovascular and renal benefits are not fully elucidated but are independent of glycemic effects.
Farxiga is indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression. It is also indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure. Additionally, it is indicated to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes and established cardiovascular disease or multiple risk factors, and as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Limitations: Not recommended for glycemic control in type 1 diabetes; not recommended for glycemic control in type 2 diabetes with eGFR less than 45 mL/min/1.73 m²; not recommended for chronic kidney disease in patients with polycystic kidney disease or those requiring or with recent history of immunosuppressive therapy for kidney disease.
Assess volume status and correct volume depletion before initiating. For glycemic control in type 2 diabetes with eGFR ≥45: start 5 mg once daily, may increase to 10 mg. For all other indications (CKD, heart failure, heart failure hospitalization reduction in type 2 diabetes): recommended dose is 10 mg once daily. For eGFR 25 to less than 45: 10 mg once daily. For eGFR less than 25: initiation not recommended, but patients may continue 10 mg once daily to reduce risk of eGFR decline, ESKD, CV death, and hHF. Withhold Farxiga for at least 3 days prior to major surgery or procedures associated with prolonged fasting.
Trial data not available in label.
Not reported in label.
Farxiga is an SGLT2 inhibitor with established benefits in type 2 diabetes, heart failure, and chronic kidney disease. It offers a therapeutic option for reducing cardiovascular and renal outcomes in patients with CKD or heart failure, regardless of diabetes status. However, it is not recommended for certain populations, such as those with polycystic kidney disease or immunosuppressive therapy for kidney disease.
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