
FDA Approves Ozempic to Prevent Kidney Failure and Death
FDA yesterday approved Ozempic (semaglutide) to prevent kidney failure and death in persons with type 2 diabetes and chronic kidney disease. This fits with one of the five trends for this year: the steady expansion of health benefits for advanced medicines used in obesity and diabetes.
But note that this approval covers the use of semaglutide only in doses used for patients with diabetes. In patients without diabetes using semaglutide, FDA hasn’t yet approved an indication for kidney disease. However, a 24-week study late last year showed some benefits in this population, too.
“Big News!”
Obesity medicine physician Mike Albert says this is big news:
“This approval means Ozempic can now be used to reduce the risk of worsening kidney disease, kidney failure, and cardiovascular death in this high-risk population – potentially changing the way we approach chronic kidney disease care.”
This approval gives semaglutide the broadest range of approved indications for any GLP-1 on the market. Those who think semaglutide is old news have another think coming. Stephen Gough, the global chief medical officer for Novo Nordisk, certainly agrees this approval is a big deal:
“Over the last 20 years, it’s been an area where researchers tried hard but delivered very little. To have something new like this is really exciting, and offers promise to patients.”
Promise to Patients Unfulfilled
This is clearly an important indication. Type 2 diabetes is the leading cause of chronic kidney disease and thus, kidney disease has become quite common as the prevalence of diabetes has grown. Gough is right that this approval offers great promise of better health for many people.
But delivery on that promise is falling short. High prices, short supply, and inadequate access to care get in the way. If we truly wish to make America healthy, someone needs to close the gap between the promise of medicines like semaglutide and their very limited availability to the many persons who need them.
The great promise of this approval will shine a brighter light on the failure of pharma and health systems to meet this challenge.
Click here, here, and here for more on this approval. For the FLOW study of semaglutide in diabetes and kidney disease, click here. Finally, for perspective on semaglutide in obesity and kidney disease, click here.
Lamb’s Kidney, photograph by Jurfeld, licensed under CC BY 4.0
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January 29, 2025