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FDA Gives Diabetic Kidney Disease Drug Priority Review

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Kidney Disease Drug

Chronic kidney disease (CKD) is one of the most troubling potential complications of diabetes, as it tends to significantly affect the quality of life of people who develop it. It’s also very expensive for the healthcare system in its later stages, when it requires regular dialysis treatments or a kidney transplant. And as we noted recently, in many people with diabetes, CKD progresses fairly rapidly after it’s first diagnosed.

Unfortunately, there aren’t currently many treatments available to help slow the progression of diabetic kidney disease. That’s one reason why a new drug being developed to treat the condition has received priority review by the U.S. Food and Drug Administration (FDA).

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Promising kidney and cardiovascular outcomes in trial

The FDA’s decision to give the new drug, finerenone, priority review was announced in a press release from Bayer, the pharmaceutical company developing it. The decision comes on the heels of a new clinical trial of the drug, published in December 2020 in The New England Journal of Medicine.

That Phase 3 trial, involving 5,734 people with both type 2 diabetes and CKD, randomly assigned participants either finerenone or a placebo (inactive pill). The researchers were interested in whether taking the new drug, on top of existing treatments that all participants were receiving, had any effect on the progression of CKD, as measured by kidney function worsening by at least 40%, kidney failure or death from kidney disease.

During a median follow-up period of 2.6 years, at least one of the adverse outcomes listed above occurred in 17.8% of the finerenone group, and in 21.1% of the placebo group. The researchers also looked at secondary outcomes — including heart attack, stroke, hospitalization for heart failure and death from cardiovascular causes — which occurred in 13.0% of the finerenone group and in 14.8% of the placebo group.

While these differences weren’t large in an absolute sense, they were statistically significant, showing that finerenone had kidney and cardiovascular benefits in people with type 2 diabetes and CKD.

Further review of data lies ahead

The next step in the drug approval process is for the FDA to complete a detailed review of the data in clinical trials of finerenone, to ensure that the drug is safe and makes a meaningful difference in treating CKD or related health problems in people with diabetes.

The FDA grants priority review to drugs that may offer a significant improvement in preventing, diagnosing or treating a serious health condition. The agency aims to make a decision on a drug application within six months under priority review, compared with 10 months under standard review.

As noted in the press release, finerenone doesn’t belong to any currently available class of drugs, representing the first drug of its kind. It’s a selective mineralocorticoid receptor antagonist (MRA) that works by blocking chemical pathways known to contribute to both kidney and cardiovascular damage. Overactivation of these pathways is believed to be a key contributor to declining kidney function, as well as cardiovascular problems, in people with CKD.

“There is currently a significant unmet medical need for the nearly 40% of people in the U.S. living with type 2 diabetes who will develop chronic kidney disease. This progressive condition can lead to kidney damage and eventual failure, despite currently available treatments,” writes Dr. Michael Devoy, Head of Medical Affairs & Pharmacovigilance of Bayer AG’s Pharmaceuticals Division, in the press release.

“Based on study data, finerenone offers a potential new strategy to delay CKD progression, while reducing the risk of cardiovascular events,” Devoy continues. “We’re encouraged that the FDA has granted the [application] a Priority Review, as it potentially expedites our ability to make finerenone available to patients.”

Want to learn more about keeping your kidneys healthy with diabetes? Read “Managing Diabetic Kidney Disease,” “Protecting Your Kidneys,” and “Kidney Disease: Your Seven-Step Plan for Prevention.” And learn more about recent research on finerenone in “Good News About Finerenone.”

Quinn Phillips

Quinn Phillips

Quinn Phillips on social media

A freelance health writer and editor based in Wisconsin, Phillips has a degree from Harvard University. He is a former Editorial Assistant for Diabetes Self-Management and has years of experience covering diabetes and related health conditions. Phillips writes on a variety of topics, but is especially interested in the intersection of health and public policy.

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