On January 28, 2025, the U.S. Food and Drug Administration (FDA) expanded the approval of Ozempic, a medication initially developed for type 2 diabetes, to include its use in patients with both type 2 diabetes and chronic kidney disease. This decision offers a new therapeutic option aimed at mitigating the progression of kidney complications, including heart disease, dialysis, and the need for kidney transplantation.
Ozempic, a glucagon-like peptide-1 receptor agonist (GLP-1 RA), functions by mimicking a natural hormone that regulates blood sugar and digestion. Specifically, it stimulates insulin release from the pancreas, reduces glucose production by the liver, slows the rate of digestion to promote satiety, and influences brain signals to decrease appetite. The FDA’s approval acknowledges the drug’s ability to reduce the risk of kidney function decline, kidney failure, and cardiovascular death in the specified patient population.
While the FDA’s action represents a significant advancement in treatment options, access to Ozempic remains a challenge for many. Barriers to access include insurance coverage variations, step therapy requirements – where insurers mandate the trial of less expensive medications first – and substantial out-of-pocket costs for patients. Current Medicare limitations, which do not cover obesity medications, further restrict access for individuals at risk of chronic kidney disease (CKD).
The National Kidney Foundation (NKF) is actively engaged in efforts to improve access to anti-obesity medications like Ozempic for individuals with kidney disease. These efforts include advocating for government drug price negotiations, with the Department of Health and Human Services (DHHS) recently announcing plans to negotiate prices for GLP-1 RAs to lower costs for Medicare beneficiaries.
The FDA has likewise issued warnings regarding Ozempic. The drug is contraindicated for patients with a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), and patients should be counseled about the potential risk of MTC and symptoms of thyroid tumors.
