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The FDA has approved Novo Nordisk’s drug Ozempic for a new use: reducing the risk of kidney disease worsening, kidney failure, and death from cardiovascular disease in adults with Type 2 diabetes and chronic kidney disease (CKD). This approval is significant because Ozempic is now the first drug in its class (GLP-1 receptor agonists) with such a broad indication. Originally approved in 2017 for Type 2 diabetes, Ozempic gained approval in 2020 to lower cardiovascular risks in these patients.
CKD affects around 37 million adults in the U.S. and commonly occurs alongside Type 2 diabetes, affecting nearly 40% of these patients. Medical experts emphasize the need for holistic care, as diabetes often comes with related health issues like heart and kidney diseases.
The FDA’s decision came after results from Ozempic’s phase 3b FLOW trial. The study showed that when combined with standard treatments, Ozempic reduced the risks of kidney disease progression, kidney failure, and cardiovascular death by 24% compared to a placebo. Additionally, it lowered major cardiovascular events by 18% and reduced the overall death risk by 20%.
Novo Nordisk’s semaglutide franchise—which includes Ozempic for diabetes, Rybelsus for diabetes, and Wegovy for obesity—is thriving, with Ozempic gaining widespread popularity partly due to its weight-loss benefits. The company is also researching semaglutide for other
conditions like liver disease, heart failure, and Alzheimer’s disease.
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