According to BioSpace, Farxiga (dapagliflozin), a treatment for patients with chronic kidney disease (CKD) and a risk of progression, recently became FDA-approved. Developed by AstraZeneca, the therapy is specifically designed for patients with or without type 2 diabetes. Altogether, the treatment was accepted under Priority Review status, but also received Fast Track designation.

Farxiga

According to AstraZeneca, Farxiga is:

a first-in-class, oral, once-daily SGLT2 inhibitor. For nearly a decade, Farxiga has been an effective monotherapy and part of combination therapy as an adjunct to diet and exercise to improve glycemic control in adults with [type 2 diabetes, but] in August 2020, results from the DAPA-CKD Phase III trial demonstrated that Farxiga achieved unprecedented reduction in the composite risk of kidney failure and [cardiovascular] or renal death in patients with CKD with or without [type 2 diabetes].

In fact, this trial was so promising that an Independent Data Monitoring Committee stopped it early, citing its extreme efficacy. Altogether, the clinical trial highlighted how:

• Farxiga significantly reduced mortality risk – from kidney or cardiovascular causes – by 31% when compared to a placebo.
• When combined with the current CKD standard of care, Farxiga lowered the risk of progressively worsening kidney function.
• Overall, the therapy can reduce the chance of reaching end-stage kidney disease, having to be hospitalized for heart failure, and the loss of estimated glomerular filtration rate (eGFR).

But there is another exciting insight into this drug’s approval: this is the first FDA approval of any SGLT2 inhibitor for patients with CKD who may or may not have type 2 diabetes. Because of this, Farxiga fulfills an unmet need within this patient population and significantly advances CKD care.

However, patients with polycystic kidney disease or who have used immunosuppressants to treat their kidney disease should not use Farxiga.

Chronic Kidney Disease (CKD)

Chronic kidney disease (CKD), or chronic kidney failure, is a condition characterized by the progressive loss of kidney function. Normally, the kidneys filter waste and excess fluid from the bloodstream. These wastes are then excreted through urine. But in patients with CKD, the kidneys are damaged, preventing them from adequately removing waste. As a result, fluids, electrolytes, and other wastes accumulate in the body. An estimated 26-37 million U.S. citizens have CKD.

Typically, CKD is caused by another condition which worsens kidney function and thus causes kidney damage. For example, having type 1 or type 2 diabetes, high blood pressure, urinary tract obstructions, recurrent kidney infections, or kidney inflammation could also cause CKD. Without intervention, CKD can progress to end-stage renal failure. Unfortunately, CKD increases the risk of heart disease, stroke, kidney transplants, and dialysis.

In some patients, symptoms will not appear until later stages. Symptoms include:

• Jaundice (yellowing of the skin and eyes)
• Appetite loss
• Nausea and vomiting
• Spleen and liver enlargement
• Stunted growth
• Difficulty sleeping
• Changes in urination frequency
• Chest pain
• High blood pressure
• Pruritus (intense and persistent itching)
• Fatigue
• General malaise
• Shortness of breath
• Swelling of the feet and ankles
• Muscle cramps or twitching
• Vitamin deficiencies