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FDA Approves Ozempic to Reduce Risk of CKD Progression

Writer's picture: Kidney Foundation of WNYKidney Foundation of WNY

The U.S. Food and Drug Administration has approved Ozempic as a treatment for adults with type 2 diabetes and chronic kidney disease to reduce the risk of kidney disease progression, kidney failure, and death due to cardiovascular disease. Novo Nordisk, the pharmaceutical company that makes Ozempic, announced the approval on Jan. 28.  

 

The FDA’s approval is based on statistically significant results from the FLOW clinical trial, which examined the effects of a weekly Ozempic injection adults with type 2 diabetes and chronic kidney disease. The trial found that participants who received the injections were 24 percent less likely to experience worsening of kidney disease, kidney failure or death due to cardiovascular disease.  

 

Ozempic (semaglutide) is in a class of drugs known as glucagon-like peptide-1 receptor agonists (GLP-1 RAs). The FDA had earlier approved Ozempic for adults with type 2 diabetes to improve glycemic control and to reduce the risk of major cardiovascular events.

 

"Chronic kidney disease is very serious and common in patients living with type 2 diabetes and represents a critical need for adults living with these comorbidities. This approval for Ozempic allows us to more broadly address conditions within cardiovascular-kidney-metabolic syndrome, which affects millions of adults and could have serious consequences if left untreated," said Anna Windle, PhD, in a news release for Novo Nordisk. She is senior vice president clinical development, medical & regulatory affairs at the pharmaceutical company.

 

"Type 2 diabetes can be challenging enough to manage without the added risk of chronic kidney disease, and I have seen in my own practice that patients with type 2 diabetes and chronic kidney disease need extra support from medications that may have a profound clinical impact by lowering the risk of major kidney and cardiovascular outcomes," Richard E. Pratley, MD, said in the same news release. Pratley is the medical director at the AdventHealth Diabetes Institute Orlando, FL, and co-chair of the FLOW Trial.

 

"A large portion of patients I treat experience serious kidney complications and comorbidities, with some even requiring dialysis,” added Pratley. “Today's decision by the FDA offers hope for the millions of adults living with both conditions and provides an additional treatment option, representing a significant advancement for my patients."


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Kidney Foundation of Western New York 
4444 Bryant and Stratton Way, Williamsville, NY 14221

716-529-4390

Serving Western New York, including Allegany, Cattaraugus, Chautauqua, Erie, Genesee,
Niagara, Orleans and Wyoming counties.

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