Is Farxiga approved for chronic kidney disease?
Yes, Farxiga (dapagliflozin) is FDA-approved to reduce the risk of kidney function decline, kidney failure, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease (CKD) at risk of progression, regardless of diabetes status. The approval came in 2023 based on the DAPA-CKD trial, which showed a 39% relative risk reduction in the composite kidney outcome versus placebo.[1][2]
How does Farxiga work in CKD?
Farxiga is an SGLT2 inhibitor that blocks glucose reabsorption in the kidneys, promoting its excretion in urine. In CKD, this lowers intraglomerular pressure, reduces proteinuria, and slows glomerular filtration rate decline. Benefits persist even in non-diabetic CKD patients with eGFR as low as 25 mL/min/1.73 m².[1][3]
Who qualifies for Farxiga in CKD?
Eligible adults have CKD stages 2-4 (eGFR 25-75 mL/min/1.73 m²), albuminuria (UACR >200 mg/g), and are on maximum tolerated ACE inhibitor or ARB therapy. It's not approved for CKD stage 5 (ESRD) or patients on dialysis.[1][2]
What do trial results show?
In the DAPA-CKD trial (4,304 patients), Farxiga cut the primary endpoint risk (≥50% eGFR decline, ESRD, or kidney/cardiovascular death) by 39% over 30 months. It also reduced heart failure hospitalizations by 29% and cardiovascular death by 31%. Absolute risk reductions were small (5.3% for primary endpoint).[3][4]
Common side effects and risks in CKD patients
Volume depletion (8%), urinary tract infections (4%), and acute kidney injury (rare) occur more often. Monitor for dehydration, especially with diuretics. Hypoglycemia risk is low without insulin or sulfonylureas. Ketoacidosis and Fournier's gangrene are black-box warnings.[1][2]
How does Farxiga compare to other CKD treatments?
Farxiga outperforms placebo and matches finerenone (steroidal MRA) in slowing CKD progression, per network meta-analyses. Unlike semaglutide (GLP-1), it's specifically labeled for non-diabetic CKD. Combination with finerenone is under study.[4][5]
| Treatment | Key CKD Benefit | Diabetes Requirement | eGFR Cutoff |
|-----------|----------------|----------------------|-------------|
| Farxiga (SGLT2i) | 39% risk reduction | No | ≥25 |
| Finerenone (MRA) | 18% risk reduction | Yes | ≥25 |
| Semaglutide (GLP-1) | 24% risk reduction | Yes | ≥20 |
Dosing and access for CKD
Start at 10 mg daily; no adjustment needed above eGFR 45, but discontinue below 25. Covered by most insurance for CKD; list price ~$600/month, with copay cards available.[1][6]
When does Farxiga's patent expire?
Core composition patent (US 6,515,117) expires in 2025, but method-of-use patents for CKD extend protection to 2032. AstraZeneca faces challenges; generics unlikely before 2026.[7]
Sources
[1]: FDA Label for Farxiga
[2]: FDA Approval Announcement
[3]: NEJM: DAPA-CKD Trial
[4]: Lancet Meta-Analysis
[5]: Kidney International Review
[6]: GoodRx Pricing
[7]: DrugPatentWatch: Farxiga Patents