The U.S. Food and Drug Administration has expanded the use of a leading injectable medication, now allowing it to be prescribed for individuals with both Type 2 diabetes and chronic kidney disease (CKD). This decision represents a major step forward in helping patients manage both conditions more effectively, reducing their risk of severe complications and improving overall quality of life.
Previously used to regulate blood sugar, this medication is now approved to help slow the progression of kidney disease, lower the likelihood of kidney failure, and decrease the risk of heart-related deaths in those affected by both conditions.
This new approval could transform the way healthcare professionals approach CKD treatment. Chronic kidney disease develops gradually, often without obvious symptoms in its early stages, but over time, it can lead to significant health problems, including the need for dialysis or a kidney transplant. According to Novo Nordisk, an estimated 37 million adults in the United States are living with some form of CKD, making it a widespread health concern that requires early intervention and proactive management.
Diabetes remains one of the biggest risk factors for CKD, with approximately 40% of individuals diagnosed with Type 2 diabetes eventually experiencing some level of kidney dysfunction. Kidney disease not only impacts the body’s ability to filter waste but also increases inflammation, elevates blood pressure, and contributes to cardiovascular disease, making comprehensive care essential.
Dr. Stephen Gough, global chief medical officer at Novo Nordisk, explained that CKD is a progressive condition that leads to a steady decline in kidney function. If left unchecked, it can eventually result in kidney failure, requiring either lifelong dialysis or a transplant. He noted that cardiovascular complications are a major concern for CKD patients, as they significantly increase the risk of premature death.
This approval highlights the expanding role of medications that were originally designed for diabetes and weight management but are now being recognized for their broader health benefits.
The FDA’s decision follows results from a major clinical study showing that the medication lowered the risk of serious kidney-related outcomes—including complete kidney failure, rapid decline in kidney function, or death due to kidney or heart disease—by 24% in people with both Type 2 diabetes and CKD, compared to a placebo.
The study also found that patients receiving the medication experienced an 18% reduction in major cardiovascular events such as heart attacks and strokes, as well as a 20% decline in overall mortality. The medication also reduced the risk of death from heart-related complications by 29%.
Dr. Gough emphasized the strong connection between kidney health and cardiovascular function, explaining that early CKD treatment often focuses on reducing cardiovascular risk factors such as high blood pressure, inflammation, and poor circulation.
The study further found that 49.6% of patients receiving the treatment reported serious adverse effects, slightly lower than the 53.8% observed in the placebo group. However, some patients experienced digestive discomfort, including nausea and vomiting, which are known side effects of this class of medications.
In December, European health regulators also approved the expanded use of this medication.
Novo Nordisk ended its phase 3 clinical trial a year earlier than planned in October after the treatment showed overwhelmingly positive results. Following the announcement, stock prices of dialysis providers dropped nearly 20%, reflecting speculation that fewer patients may require dialysis in the future.
The trial, called FLOW, began in 2019 and followed around 3,500 individuals with Type 2 diabetes and moderate to severe CKD.
Dr. Gough pointed out that conditions like diabetes, obesity, kidney disease, and cardiovascular disease are often interconnected. A treatment that addresses multiple concerns in a single injection offers a significant advantage in chronic disease management.
The FDA’s approval comes at a time when the Biden administration is working on Medicare drug price negotiations, which include this medication and two other Novo Nordisk products containing the same active ingredient—one for weight management and another for oral diabetes treatment.
Meanwhile, Novo Nordisk continues to compete with Eli Lilly and is pushing for expanded insurance coverage of its weight-loss medication. In 2023, the weight-loss version of this medication was also approved for reducing the risk of heart attacks and strokes, and research is ongoing to explore its benefits for liver health.
This latest approval further reinforces the importance of a holistic approach to health, where medical treatments, lifestyle changes, and preventive care all play a role in managing chronic conditions. With its expanded use, this medication offers new hope for individuals looking to take control of their health and prevent long-term complications.