The new approval means that Farxiga has been found to be an effective treatment for chronic kidney disease, regardless of whether a person has diabetes. But diabetes is the most common cause of chronic kidney disease, so most people who take the drug for this purpose are likely to have diabetes. The FDA found that taking Farxiga may “reduce the risk of kidney function decline, kidney failure, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease who are at risk of disease progression.” Farxiga has been approved as a treatment for type 2 diabetes since 2014.
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Farxiga found to improve kidney outcomes
As described in the news release, the latest approval is based on a study involving 4,304 participants who were randomly assigned to take either Farxiga or a placebo (inactive pill) for their chronic kidney disease. The researchers looked at how many people in each group reached a composite (combined) endpoint — either a 50% reduction in kidney function, progression to kidney failure, or death from cardiovascular or kidney-related causes. Out of 2,152 participants in each group, the Farxiga group saw 197 people reach the composite endpoint, while the placebo group saw 312 reach this endpoint — meaning the Farxiga group had about a 37% lower risk of this combined outcome.
The study also compared the number of people in each group who were hospitalized for heart failure or died from cardiovascular causes. A total of 100 people in the Farxiga group reach this combined endpoint, while 138 people in the placebo group did — representing about a 28% lower risk for this outcome in the Farxiga group.
The FDA noted that Farxiga was not studied for, and is not meant to treat, two genetic forms of chronic kidney disease — autosomal dominant kidney disease and recessive polycystic kidney disease (characterized by multiple cysts). It’s also not intended for people who receive, or have recently received, immunosuppressive therapy to treat their kidney disease.
As doctors who prescribe Farxiga should know, people with diabetes who take insulin and start taking Farxiga may need to reduce their doses of insulin to avoid hypoglycemia (low blood glucose), since Farxiga can lower blood glucose even if it’s prescribed mostly for its kidney benefits.
“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,” said Aliza Thompson, MD, deputy director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research, in the news release. “Today’s approval of Farxiga for the treatment of chronic kidney disease is an important step forward in helping people living with kidney disease.”
Want to learn more about keeping your kidneys healthy with diabetes? Read “How to Keep Your Kidneys Healthy,” “Kidney Disease: Your Seven-Step Plan for Prevention” and “Ten Things to Know About Kidney Disease.”
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