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FDA Expands Approval of Ozempic to Reduce Kidney and Cardiovascular Risks in Type 2 Diabetes Patients.
Danish pharmaceutical company Novo Nordisk has announced that the U.S. Food and Drug Administration (FDA) has approved an expanded use of its drug Ozempic (semaglutide). The medication can now be prescribed to reduce the risk of worsening kidney disease, kidney failure, and cardiovascular-related mortality in adults with type 2 diabetes and chronic kidney disease (CKD).
A Significant Advancement in Patient Care
This approval marks a major breakthrough in healthcare, particularly given the limited treatment options available for CKD patients. It paves the way for improved quality of life and better health outcomes for those at risk.
How Ozempic Works
Ozempic contains the active ingredient semaglutide, which belongs to a class of drugs known as GLP-1 receptor agonists (glucagon-like peptide-1 receptor agonists). It functions through multiple mechanisms, including stimulating insulin secretion when needed, reducing glucose production in the liver, and slowing gastric emptying, ultimately lowering blood sugar levels and helping control appetite.
Type 2 diabetes is a leading cause of chronic kidney disease, as persistently high blood sugar levels can damage the blood vessels in the kidneys, impairing their ability to filter waste from the bloodstream. This makes Ozempic a crucial tool in slowing disease progression and reducing associated complications.
Proven Effectiveness in Kidney Protection
The FDA’s decision was based on clinical studies demonstrating that Ozempic reduces the risk of severe complications in patients with type 2 diabetes and CKD by 24% compared to those receiving a placebo. These complications include the need for dialysis or kidney transplantation, as well as a significant reduction in cardiovascular-related mortality rates.
Commenting on this milestone, Dr. Stephen Gough, Senior Vice President of Global Medical Affairs at Novo Nordisk, told The New York Times: “For the past two decades, researchers have struggled to find effective solutions for chronic kidney disease patients, but progress has been limited. This approval represents a significant step forward in offering new hope to those affected.”
Although the precise mechanism by which Ozempic benefits kidney health remains unclear, researchers believe it may help reduce inflammation throughout the body, including in the kidneys, potentially slowing disease progression.
Novo Nordisk officially announced the FDA’s expanded approval on its website on January 28. The New York Times also highlighted the significance of this development in a dedicated report.