February 2025
Published: 31 Jan 2025
Author: Precedence Research
The U.S. FDA has approved Ozempic (semaglutide) to lessen the risk of advancement from chronic kidney disease (CKD) to kidney failure and cardiovascular-related death in adults with type 2 diabetes and CKD. The decision is considered an advancement in the treatment of important comorbidity of diabetes, thereby making Ozempic the most widely indicated GLP-1 receptor agonist (GLP-1 RA) on the market.
Chronic kidney disease is a serious and common disadvantage for nearly 37 million adults in the U.S., diabetes being the foremost cause. Around 40% of the individuals having type 2 diabetes are also having CKD, which puts tremendous strain on the healthcare system and the patients themselves.
The FDA approved Ozempic to enhance kidney and cardiovascular outcomes in adults with type 2 diabetes and chronic kidney disease (CKD). In the Phase 3b FLOW trial, 3,533 participants across 28 countries were enrolled, and Ozempic 1 mg was reported to cause a 24% relative risk reduction vs placebo in the incidence of the composite outcome of worsening kidney disease, kidney failure, and death, due to cardiovascular disease. The trial confirmed that Ozempic is efficacious in reducing the rate of decline of kidney function and reducing cardiovascular deaths.
The additional indication for Ozempic will benefit patients challenged by both diseases because it enhances blood sugar control, protects kidney function, and decreases cardiovascular risk. This intervention might also lead to savings in advanced CKD treatments and hospitalization. Patients on the brink of requiring dialysis or with imminent kidney failure may postpone or even prevent treatment with Ozempic. Furthermore, those at risk for heart attacks, strokes, or cardiovascular death thirty-six months down the line due to the double burden of diabetes and CKD will receive supplementary cardiovascular protection.
The potency of Ozempic was first conferred by the FDA in 2017 for the ameliorative management of blood glucose levels in type 2 diabetic adults. The drug received approval in 2020 for its usefulness in reducing the risk of cardiovascular events (CVEs) in patients with type 2 diabetes and those with cardiovascular disease. Ozempic gained an extended indication in 2025 to include the prevention of complications related to chronic kidney disease, thus being awarded the widest indication of all GLP-1 RA within its class of compounds. This represents the expanding appreciation of the concepts of cardiovascular-kidney-metabolic (CKM) syndrome, which designs metabolic disease interplay with cardiovascular health and kidney function topics. In light of this, experts profess that the likes of Ozempic will bring the turn of the tides in clinical practice guidelines to focus more on early intervention for at-risk patients.
No doubt is left that the recent approval by the FDA for Ozempic Plus in CKD-related complications presents a landmark advancement in diabetes management. This new indication decreases the risk of progression to kidney disease and mortality from cardiovascular issues, giving hope to millions of patients. It also accentuates the growing role of GLP-1 receptor agonists in warding off major complications, thereby improving long-term health outcomes.
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