April 30, 2021

The U.S. FDA has approved a new indication for Farxiga® (dapagliflozin), manufactured by AstraZeneca. The drug is now indicated for use in adults who have chronic kidney disease (CKD) at risk of progression to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease (ESKD), cardiovascular (CV) death, and hospitalization for heart failure (hHF).

CKD occurs when damage to the kidneys prevents them from filtering blood normally. This can cause fluid, electrolytes, and waste to build up to dangerous levels in the body. Patients who have CKD may develop kidney failure, at which point dialysis or kidney transplant are required to prolong life. They are also at high risk of cardiovascular disease. Common causes of CKD include diabetes and high blood pressure, though it can also be caused by infection, autoimmune disease, medications, heavy metal (such as lead) poisoning, genetics, and other factors.

In clinical studies, Farxiga added to standard-of-care treatment reduced the relative risk of worsening kidney function, onset of ESKD, or risk of CV or renal death by 39% compared to placebo in patients diagnosed with CKD Stages 2-4. It also reduced the relative risk of death from any cause by 31% compared to placebo. Additional analysis supports the likelihood of Farxiga to be effective in patients whose CKD is less advanced. However, Farxiga is not recommended to treat CKD in patients who have polycystic kidney disease or who require or have a recent history of immunosuppressive therapy for kidney disease.

Recommended dosing under the new indication is 10mg taken by mouth once daily. Initiation of Farxiga is not recommended in patients whose eGFR is less than 25mL/min/1.73m2, though treatment can be continued if these patients were already taking Farxiga. The drug is contraindicated for patients who are on dialysis.

Farxiga first received FDA approval in 2014 and is also indicated to treat type 2 diabetes and to reduce the risk of CV death or hospitalization in adults who have heart failure with reduced ejection fraction.

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