The U.S. Food and Drug Administration has approved Novo Nordisk’s widely used injectable medication for an expanded indication, allowing its use in patients with both Type 2 diabetes and chronic kidney disease (CKD). This decision represents a major advancement in the treatment of kidney-related complications in diabetic patients and could significantly impact clinical practice.
Originally developed as a glucose-regulating therapy, this medication is now approved to help slow kidney function decline, reduce the likelihood of kidney failure, and lower the risk of cardiovascular-related mortality in individuals managing both conditions.
This regulatory approval is expected to change the approach to CKD management, a condition characterized by a gradual loss of kidney function that can ultimately lead to dialysis or transplantation. According to Novo Nordisk, an estimated 37 million adults in the U.S. are affected by CKD, making this a pressing public health concern.
Diabetes is one of the most significant risk factors for kidney disease, with nearly 40% of individuals diagnosed with Type 2 diabetes eventually developing CKD. Beyond the progressive loss of kidney function, this condition also elevates the risk of cardiovascular complications and early mortality, making effective intervention critical.
Dr. Stephen Gough, Novo Nordisk’s global chief medical officer, emphasized that CKD is a chronic, progressive disease that steadily diminishes kidney function. When kidney failure occurs, patients require either ongoing dialysis or a kidney transplant—both of which present significant medical and logistical challenges. He noted that mortality rates among patients with end-stage kidney disease remain high, particularly due to cardiovascular complications.
The approval underscores the expanding role of glucagon-like peptide-1 receptor agonists (GLP-1 RAs), a class of medications initially designed for diabetes management but now recognized for their broader systemic benefits.
The decision follows compelling evidence from a phase 3 clinical trial demonstrating that the medication reduced the risk of severe kidney-related outcomes—including kidney failure, rapid loss of function, or death due to kidney or heart disease—by 24% in patients with Type 2 diabetes and CKD, compared to a placebo.
Additionally, the study found that patients taking the medication experienced an 18% reduction in major cardiovascular events, such as heart attacks, and a 20% decrease in overall mortality. The risk of cardiovascular-related deaths was reduced by 29%.
Dr. Gough highlighted the strong relationship between CKD and cardiovascular disease, noting that medical interventions aimed at kidney protection must also focus on reducing cardiovascular risks, such as managing hypertension.
The clinical trial data further revealed that 49.6% of patients receiving the treatment reported serious adverse effects, slightly lower than the 53.8% observed in the placebo group. While gastrointestinal symptoms such as nausea and vomiting were more common in those receiving the medication, these effects align with the established safety profile of GLP-1 receptor agonists.
European health authorities approved the same expanded use of the medication in December.
Novo Nordisk concluded its phase 3 study ahead of schedule in October after an independent review found overwhelmingly positive results. The announcement led to a sharp decline—nearly 20%—in the stock prices of dialysis providers, as the findings suggest a reduced long-term need for dialysis among patients with CKD.
The trial, known as FLOW, began in 2019 and followed approximately 3,500 patients with Type 2 diabetes and moderate to severe CKD.
Dr. Gough emphasized that metabolic disorders—including diabetes, obesity, CKD, and cardiovascular disease—often overlap in patients, creating a need for comprehensive treatment approaches. He noted that a therapy capable of addressing multiple comorbidities in a single injection offers a significant step forward in chronic disease management.
The FDA’s approval comes amid ongoing Medicare drug price negotiations under the Biden administration, which include this therapy and two additional Novo Nordisk medications containing the same active ingredient—a weight-loss formulation and an oral diabetes treatment.
Novo Nordisk also faces increasing competition from Eli Lilly while working to expand insurance coverage for its weight-loss medication. In 2023, the company secured FDA approval for the weight-loss version to help reduce the risk of major cardiovascular events, such as heart attacks and strokes, and is now studying its potential for treating liver disease.
This latest approval further strengthens the role of GLP-1 receptor agonists as an essential component of modern chronic disease management, demonstrating their potential beyond glucose control and weight loss to improve kidney and cardiovascular health outcomes.