FDA approves Ozempic for kidney disease

In this article:

• What is Ozempic?
• Benefits for kidney disease
• Other uses
• What's next?

In this article

• What is Ozempic?
• Benefits for kidney disease
• Other uses
• What's next?

The blockbuster GLP-1 drug Ozempic has received approval for yet another chronic medical condition. The U.S. Food and Drug Administration (FDA) expanded Ozempic’s indication to reduce the risk of kidney disease worsening, kidney failure, and death due to cardiovascular disease in adults with Type 2 diabetes and chronic kidney disease (CKD). 

“Chronic kidney disease is very serious and common in patients living with Type 2 diabetes and represents a critical need for adults living with these comorbidities. 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, Ph.D., Senior Vice President of Clinical Development, Medical & Regulatory Affairs at Novo Nordisk in a statement. 

What is Ozempic?

Ozempic is an injectable form of semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist. It was first approved by the FDA in 2017 for people with Type 2 diabetes to help with blood sugar control, in addition to diet and exercise. Clinical trials showed that the medication could help people with Type 2 diabetes lower their hemoglobin A1C (HbA1c), a blood test that shows average blood sugar levels over a three-month period. 

Ozempic injections are given once a week to help stimulate the pancreas to produce more of the hormone insulin. Insulin helps move sugar from the bloodstream into the body’s cells so it can be used for energy. Reducing the amount of sugar in the bloodstream helps reduce the potential damage that can occur to the blood vessels from high blood sugar. 

Benefits for people with kidney disease

The expanded approval for Ozempic is significant because people with Type 2 diabetes and CKD are at high risk for kidney failure and cardiovascular events, as a recent study in the New England Journal of Medicine noted. 

CKD is a common complication of diabetes—37 million adults are living with CKD in the U.S. Diabetes cases are on the rise nationwide, so those numbers could increase. This approval is a game-changer for these Americans. 

According to the National Kidney Foundation, risk factors for chronic kidney disease include:

• Diabetes
• Obesity
• Hypertension (high blood pressure)
• Heart failure
• Heart disease
• Increasing age (older than age 60)
• Family history of CKD or kidney failure
• History of smoking or tobacco use
• Personal history of acute kidney injury

The longer someone has CKD, the greater the risk of serious complications. They might begin to develop cardiovascular disease, high blood pressure, high levels of potassium in their blood, a buildup of acid in the bloodstream, and even kidney failure. 

According to Novo Nordisk, the approval resulted from the FLOW phase 3b kidney outcomes trial. The trial found that adults with Type 2 diabetes and CKD who received a weekly injection of 1 mg of Ozempic experienced “a statistically significant and superior 24% relative risk reduction of kidney disease worsening, kidney failure (end-stage kidney disease), and death due to cardiovascular disease (4.9% absolute risk reduction at 3 years) compared to placebo when added to standard of care.” In other words, it was very effective at preventing CKD from worsening.

However, Ozempic may not be the right choice for everyone with CKD. People with a personal or family history of medullary thyroid carcinoma (MTC), or an endocrine condition called Multiple Endocrine Neoplasia Syndrome Type 2 (MEN 2) should not take this medication. Tell your healthcare provider if you have any other medication conditions, especially pancreatitis.

Other approved uses of semaglutide

This is not the first time that the FDA has expanded the use of semaglutide. 

Although Ozempic started as a Type 2 diabetes treatment, it quickly became known for another benefit: many people who began taking Ozempic to improve their glycemic control also noticed that it helped them lose weight. The medication curbed their appetite and slowed down the emptying of their stomachs. The result: they felt full longer, a state called satiety. As their appetite waned, they were less likely to eat as much, which enhanced their weight loss. 

Heart disease

In turn, the weight loss helped improve other chronic medical conditions. Many people on Ozempic found that their blood pressure and cholesterol levels decreased, which improved their cardiovascular health. In fact, the FDA expanded the use of Ozempic in 2020 to reduce the risk of heart attack, stroke, or death in adults with Type 2 diabetes with known heart disease.

Weight loss

Clinical trials showed that people who received weekly injections of semaglutide were able to lose significantly more weight than people taking a placebo (inactive medicine) or other meds. For example, in one clinical trial, patients lost about 15% of their total body weight while taking 2.4 mg of semaglutide weekly, with lifestyle interventions. Those kinds of results paved the way for the FDA to approve Wegovy (semaglutide) in 2021 specifically for weight loss in adults who are obese or overweight and have at least one weight-related medical condition. 

Semaglutide became so popular that shortages of both Ozempic and Wegovy developed, as people clamored for drugs to help them lose weight and improve their health. 

What’s next?

As research continues, Ozempic–and other GLP-1s—may be approved for even more uses. For example, a new study published in the journal Nature Medicine even suggested that GLP-1 receptor agonists could help decrease the risk of developing dementia. Additionally, other GLP-1 drugs have gained approval for additional conditions as well. In late 2024, the FDA approved Zepbound (tirzepatide) for the treatment of obstructive sleep apnea, a condition common among obese or overweight people. Previously, Zepbound was only approved for chronic weight management.