In this article, the Food and Drug Administration has approved Novo Nordisk’s Ozempic for the treatment of chronic kidney disease in patients with Type 2 diabetes. This approval expands the use of the injection in the U.S., where it is already widely used to treat Type 2 diabetes. Ozempic can now be used to reduce the risk of kidney disease progression, kidney failure, and death from cardiovascular disease in patients with both chronic kidney disease and diabetes.
This decision has the potential to change how doctors manage patients with chronic kidney disease, a condition characterized by a gradual decline in kidney function and a leading cause of death in the U.S. Approximately 37 million American adults are living with chronic kidney disease, according to Novo Nordisk. Diabetes is a significant risk factor for kidney disease, with around 40% of Type 2 diabetes patients also having chronic kidney disease, leading to additional health issues such as an increased risk of cardiovascular problems and death.
Novo Nordisk’s global chief medical officer, Stephen Gough, highlighted the progressive nature of chronic kidney disease, emphasizing the relentless decline in renal function over time. When the disease advances to end-stage kidney disease, patients often require long-term dialysis or a kidney transplant, both of which are burdensome and associated with a high risk of death, particularly from cardiovascular causes.
The approval of Ozempic underscores the broader health benefits of GLP-1 drugs beyond managing blood sugar levels and appetite suppression. Clinical trials showed that Ozempic reduced the risk of severe kidney outcomes, slowed the decline in kidney function, and lowered the risk of major cardiovascular events and death compared to a placebo. The drug also decreased the risk of cardiovascular-related deaths.
The rate of serious adverse side effects was lower in patients taking Ozempic compared to those on a placebo, with gastrointestinal side effects being the most common reason for discontinuation among Ozempic users. The European Union regulators had previously approved Ozempic for the same indication in December.
Novo Nordisk’s phase three trial, FLOW, which ended early due to positive results, followed approximately 3,500 patients with diabetes and moderate to severe chronic kidney disease. The company’s active ingredient semaglutide, found in drugs like Ozempic, Wegovy, and Rybelsus, was selected by the Biden administration for Medicare drug price negotiations.
As Novo Nordisk faces increased competition from Eli Lilly and seeks expanded insurance coverage for Wegovy, the FDA’s approval of Ozempic for chronic kidney disease in diabetic patients marks a significant milestone in the treatment of these interconnected health conditions.
