
The FDA has approved Novo Nordisk’s Ozempic to treat chronic kidney disease (CKD) in patients with Type 2 diabetes, expanding its role beyond diabetes management. Previously used primarily for blood sugar control and weight loss, Ozempic can now help slow kidney function decline, reduce the risk of kidney failure, and lower the chances of death from cardiovascular disease in these patients. This approval is significant, as CKD affects around 37 million American adults and is a major cause of death in the U.S. Diabetes is a key contributor to CKD, with approximately 40% of Type 2 diabetes patients developing kidney disease, which increases the risk of heart issues and mortality.
A major late-stage trial, called FLOW, tracked 3,500 patients with diabetes and moderate to severe CKD. The results showed that Ozempic reduced severe kidney-related complications—including kidney failure and death from heart or kidney causes—by 24% compared to a placebo. Additionally, it lowered the risk of major cardiovascular events like heart attacks by 18% and reduced overall mortality by 20%. Cardiovascular-related deaths dropped by 29%. These findings reinforce the link between kidney disease and heart health, showing that addressing one condition can benefit the other.
The approval also highlights the broader health benefits of GLP-1 drugs, a class of medications that include Ozempic and its weight loss-focused counterpart, Wegovy. While they are mainly known for managing diabetes and obesity, these drugs are proving to have significant effects on other chronic conditions. However, gastrointestinal side effects such as nausea and vomiting were reported, leading some patients to discontinue treatment.
The FDA’s decision follows similar approval in Europe in December and comes at a time when Novo Nordisk is facing increased competition from Eli Lilly and scrutiny over drug pricing. The Biden administration has selected Ozempic, Wegovy, and another Novo Nordisk drug, Rybelsus, for Medicare drug price negotiations. As Novo Nordisk works to expand insurance coverage for Wegovy and explore its use in treating fatty liver disease, this new approval for Ozempic further strengthens the company’s position in the GLP-1 drug market.
Source: www.cnbc.com/2025/01/28/novo-nordisks-ozempic-wins-fda-approval-for-chronic-kidney-disease.html