The U.S. Food and Drug Administration (FDA) has approved the new drug Kerendia (finerenone) as treatment for kidney and heart complications in people with chronic kidney disease linked to type 2 diabetes, according to a statement from the FDA.
The approval comes after the FDA gave the drug priority review status in January 2021, based on the promising results of a clinical trial. That trial also serves as the basis for the drug’s approval, which means that the pharmaceutical company Bayer is free to sell and market Kerendia in the United States. There were 5,674 participants who completed the clinical trial, who were each randomly assigned to receive either Kerendia or a placebo (inactive pill). All participants had type 2 diabetes and chronic kidney disease at the start of the trial.
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The researchers looked at how many people in each group (Kerendia or placebo) reached at least one of the following outcomes related to kidney disease — at least a 40% reduction in kidney function, progression to kidney failure, or death from kidney disease. Kidney failure means that a person’s kidneys can no longer filter waste products from the blood, and dialysis or a kidney transplant is needed to stay alive. During the trial’s follow-up period (a median of 2.6 years), 504 out of 2,833 people (17.8%) in the Kerendia group experienced at least one of these outcomes, while 600 out of 2,841 people (21.1%) n the placebo group did.
The researchers also looked at secondary outcomes that weren’t directly related to kidney disease — including heart attack, stroke, and death from cardiovascular causes — and found that these outcomes occurred in 13.0% of people in the Kerendia group and 14.8% of people in the placebo group. While the absolute differences in these numbers aren’t especially large, the results of the trial show that taking Kerendia makes a statistically significant difference in both the course of chronic kidney disease and cardiovascular outcomes in people with type 2 diabetes.
As noted in the FDA’s statement, side effects of Kerendia may include high levels of potassium or sodium in the blood, as well as abnormally low blood pressure. People with certain health conditions (such as adrenal insufficiency) or those who take drugs known as CYP3A4 inhibitors shouldn’t take Kerendia.
“We are excited to bring this new kidney-focused treatment to people living with this condition,” said Amit Sharma, MD, vice president of cardiovascular and renal medical affairs at Bayer, in a press release from the company. Sharma noted that Kerendia is the only drug of its kind that is proven to slow the progression of chronic kidney disease and reduce the cardiovascular risk in this population of people with type 2 diabetes.
As always, talk to your doctor if you have any questions about whether you might benefit from taking Kerendia or any other drug for your diabetes or related complications.
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.”
Source URL: https://www.diabetesselfmanagement.com/news-research/2021/07/14/kerendia-drug-for-diabetic-kidney-disease-gets-fda-approval/
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