The FDA has approved Novo Nordisk’s Ozempic (semaglutide) for reducing the risk of kidney failure, progression of kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease (CKD).
The approval marks Ozempic as the first GLP-1 receptor agonist (GLP-1 RA) authorized in a kidney disease indication.
It also marks the third FDA approval for Ozempic, which has become a global blockbuster as a treatment for type 2 diabetes and off label use for weight loss.
Ozempic was initially approved by the FDA in 2017 for blood sugar control in adults with type 2 diabetes, along with diet and exercise. In 2020, it received approval in an additional indication to reduce the risk of major cardiovascular events (MACE), such as heart attack, stroke or death, in adults with type 2 diabetes and known heart disease.
CKD is a common complication of type 2 diabetes that affects approximately 40% of individuals with the condition. In the US alone, about 37 million adults are impacted by CKD.
XTALKS WEBINAR: GLP-1 Agonist Development: Endpoint Strategies to Help Differentiate Your Drug
Live and On-Demand: Tuesday, February 25, 2025, at 11am EST (5pm CET/EU-Central)
Register for this free webinar to gain insights into strategies for leveraging innovative endpoint solutions to enhance the safety, efficacy and patient-focused value of GLP-1 clinical trials.
The FDA’s decision was based on data from the FLOW Phase IIIb kidney outcomes trial, which investigated the effects of once-weekly Ozempic 1 mg injections on major kidney and cardiovascular outcomes in adults with type 2 diabetes and CKD.
The study included about 3,500 participants and was conducted in 28 countries involving around 400 investigator sites.
The trial demonstrated a 24% relative risk reduction in kidney disease worsening, kidney failure (end-stage kidney disease) and death due to cardiovascular disease compared to placebo, when added to standard care.
“This approval for Ozempic allows us to more broadly address conditions within cardiovascular-kidney-metabolic syndrome, which affects millions of adults and could have serious consequences if left untreated,” said Anna Windle, PhD, senior vice president of Clinical Development, Medical & Regulatory Affairs at Novo Nordisk. “With this new indication, Ozempic stands out uniquely as the most broadly indicated GLP-1 RA in its class.”
Related: GLP-1 Drugs Mounjaro, Zepbound, Wegovy Back in Stock After Extended Shortages
Last year, the FDA approved Novo’s obesity semaglutide formulation Wegovy for reducing the risk of stroke and heart attack in overweight or obese adults who do not have diabetes.
Novo is also exploring semaglutide’s potential in a variety of other conditions, including metabolic dysfunction-associated steatohepatitis (MASH), heart failure and Alzheimer’s disease.
With billions in annual sales, Ozempic and Wegovy have been driving an exponentially growing obesity market for their weight loss benefits.
Both drugs have been plagued by persistent supply shortages for the last several years due to immense demand.
If you want your company to be featured on Xtalks.com, please email [email protected].
Join or login to leave a comment
JOIN LOGIN