FDA Greenlights AstraZeneca’s Farxiga for Chronic Kidney Disease

May 04, 2021 - FDA recently approved AstraZeneca’s Farxiga oral tablets to reduce the risk of kidney function decline, kidney failure, cardiovascular, death, and hospitalization for heart failure in adults with chronic kidney disease. 

Farxiga was originally approved in 2014 to improve glycemic control in adults with type 2 diabetes.

“Chronic kidney disease is an important public health issue, and there is a significant unmet need for therapies that slow disease progression and improve outcomes,” Aliza Thompson, MD, MS, deputy director of the division of cardiology and nephrology in the FDA’s center for drug evaluation and research, said in the announcement. 

“Today’s approval of Farxiga for the treatment of chronic kidney disease is an important step forward in helping people living with kidney disease,” Thompson continued. 

FDA based its decision on a multicenter, double-blind study, which evaluated the efficacy of Farxiga to improve kidney outcomes and reduce cardiovascular death in patients with chronic kidney disease in 4,304 patients. 

The study compared two groups to uncover the number of patients whose disease progressed to a composite or combined endpoint that included at least a 50 percent reduction in kidney function, progression to kidney failure, or cardiovascular or kidney death. 

Researchers found that 197 of the 2,152 patients who received Farxiga had at least one of the composite endpoint events compared to 312 of the 2,152 patients who received placebo. 

For example, Farxiga, along with standard-of-care treatment, reduced the relative risk of worsening of renal function or renal death by 39 percent compared to placebo in patients with chronic kidney disease stages two through four.

This was the primary composite endpoint.

Additionally, 100 patients who received Farxiga were hospitalized or died compared to 138 patients who received placebo. 

FDA stated that Farxiga was not studied or expected to be effective in treating chronic kidney disease among patients with various conditions, including autosomal dominant or recessive polycystic kidney disease. 

The agency warned that patients should not use Farxiga if they have a history of hypersensitivity reactions to the medication or if they are on dialysis treatment. 

Additionally, the medication may cause dehydration, serious urinary tract infections, metabolic acidosis, or ketoacidosis. Patients should also be assessed for their volume status and kidney function before starting Farxiga. 

Mene Pangalos, executive vice president of biopharmaceuticals research and development at AstraZeneca, stated that FDA’s approval of Farxiga is the most significant advancement of chronic kidney disease in over 20 years.

“We’ve shown impressive efficacy for Farxiga in type-2 diabetes, heart failure with reduced ejection fraction and, most recently, chronic kidney disease and we are thrilled to be able to bring this medicine to millions of patients in the US,” Pangalos said in a statement.

Chronic kidney disease occurs when the kidneys are damaged and cannot filter blood normally, FDA stated. Patients can have complications related to fluid, electrolytes, and waste build-up in the body. 

Chronic kidney disease sometimes can progress to kidney failure. Kidney failure affects almost 750,000 people per year in the US. Individuals who are affected by kidney failure are also at high risk of cardiovascular disease, including heart disease and stroke. 

Before the emergence of drugs like sunitinib, kidney cancer had a poor prognosis, with a median overall survival of less than a year, Robert Motzer, MD, of Memorial Sloan Kettering Cancer Center, said in an article. 

Although there are some issues with developing kidney care drugs, various drugs are currently FDA approved, including Afinitor (Everolimus), Avelumab, Cabometyx, Ipilimumab, Lenvima, Nexavar, Proleukin, Sutent, Torisel, Votrient, and 35 others.