Ozempic Breakthrough: FDA Expands Use to Fight Kidney Disease in Type 2 Diabetes

on
January 29, 2025

The U.S. Food and Drug Administration has approved Novo Nordisk’s Ozempic (semaglutide) to reduce the risk of kidney disease progression, kidney failure, and cardiovascular-related death in patients who have both chronic kidney disease (CKD) and type 2 diabetes.

•In the pivotal FLOW trial of roughly 3,500 participants, Ozempic reduced the risk of severe kidney outcomes (including kidney failure and significant declines in kidney function) by 24% compared to placebo.

•Patients also saw an 18% reduction in major cardiovascular events and a 20% decrease in the risk of death from any cause.

•Kidney function declined more slowly, highlighting the potential to lessen the burden of end-stage renal disease and reliance on dialysis.

"All chronic kidney disease is progressive. It’s a year-on-year, relentless decline in renal function" – Dr. Stephen Gough, Global Chief Medical Officer, Novo Nordisk

Why It Matters for Physicians:

GLP-1 receptor agonists like semaglutide are demonstrating broad cardiometabolic benefits, now extending beyond type 2 diabetes and obesity into the realm of CKD management.

• This approval offers an important new therapeutic option that targets multiple comorbidities in a single injection, potentially shifting standard practice in the management of diabetic kidney disease.