The U.S. Food and Drug Administration (FDA) has approved an expanded use of Novo Nordisk's Ozempic® (semaglutide).
The drug is now approved to reduce the risk of kidney disease progression, kidney failure and cardiovascular death in adults with type 2 diabetes and chronic kidney disease (CKD). This extension complements Ozempic's existing indications to improve glycemic control and reduce serious cardiovascular events in adults with type 2 diabetes and heart disease.
The FDA approval is based on the results of the FLOW Phase 3b renal study. The study showed that Ozempic® 1 mg significantly reduced the relative risk of worsening kidney disease, kidney failure and cardiovascular death by 24% compared to a placebo in addition to standard care. In addition, an absolute risk reduction of 4.9% was observed over a three-year period.
CKD is a common comorbidity in people with type 2 diabetes and affects around 40% of patients. This condition can lead to further health complications, including an increased risk of cardiovascular problems and mortality. The results of the FLOW study suggest that Ozempic® may offer a significant clinical benefit in mitigating these risks.
Ozempic®, a glucagon-like peptide-1 receptor agonist (GLP-1 RA), received its first FDA approval in 2017.
It is used to control blood glucose levels in combination with diet and exercise in adults with type 2 diabetes. This was followed in 2020 by an additional approval to reduce the risk of serious cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes and known heart disease.
The expanded use positions Ozempic® as the most broadly indicated GLP-1 RA in its category and could open up important treatment options for millions of adults with type 2 diabetes and CKD.
Novo Nordisk is the only FDA-approved manufacturer of semaglutide drugs such as Ozempic®.
