Ozempic: FDA Greenlights Groundbreaking Diagnosis and Treatment for Type 2 Diabetes and Kidney Disease

Ozempic® (semaglutide) has received a landmark approval from the U.S. Food and Drug Administration (FDA), marking a significant advancement in the Approved Diagnosis For Ozempic and its therapeutic applications. This decision expands Ozempic’s indication to reduce the risk of kidney disease progression, kidney failure, and cardiovascular death in adults grappling with type 2 diabetes and chronic kidney disease (CKD). This approval positions Ozempic® as the only glucagon-like peptide-1 receptor agonist (GLP-1 RA) with this comprehensive benefit, addressing a critical unmet need for millions.

This pivotal FDA decision is rooted in the compelling outcomes of the FLOW phase 3b kidney trial. These results underscore Ozempic’s ability to significantly improve outcomes for a vulnerable population facing the intertwined challenges of type 2 diabetes and CKD. Ozempic was already recognized for its effectiveness in managing blood sugar and reducing cardiovascular risks in type 2 diabetes patients with heart disease. This new indication broadens its impact, solidifying its role in treating complex cardiometabolic conditions.

“The co-occurrence of chronic kidney disease and type 2 diabetes presents a formidable health challenge. This FDA approval for Ozempic® is a crucial step forward, offering a much-needed treatment option for adults facing these interconnected conditions,” stated Dr. Anna Windle, Senior Vice President at Novo Nordisk. “Ozempic® now stands alone as the most broadly indicated GLP-1 RA, reflecting our dedication to developing innovative solutions that meaningfully improve patient lives within the cardiovascular-kidney-metabolic spectrum.”

Chronic kidney disease is a widespread and serious condition, affecting approximately 37 million adults in the United States, with prevalence expected to rise. A significant driver of CKD is diabetes, with around 40% of type 2 diabetes patients also developing CKD. This comorbidity significantly worsens patient prognosis, increasing the risk of cardiovascular complications and mortality.

The FLOW trial, a rigorous phase 3b study, investigated Ozempic’s impact on kidney and cardiovascular outcomes in adults with type 2 diabetes and CKD. The trial’s findings were decisive: Ozempic® 1 mg demonstrated a statistically significant 24% relative reduction in the risk of kidney disease worsening, kidney failure, and cardiovascular death compared to placebo, when added to standard care. This translates to a notable 4.9% absolute risk reduction over a 3-year period.

Dr. Richard E. Pratley, Medical Director at the AdventHealth Diabetes Institute, and a co-chair of the FLOW Trial, emphasized the clinical significance of this approval. “Managing type 2 diabetes is already complex, and the added burden of chronic kidney disease necessitates more effective therapeutic strategies. The FDA’s decision to approve Ozempic® for this expanded indication offers new hope for millions. It provides an invaluable tool for clinicians to significantly reduce the risk of major kidney and cardiovascular events in this high-risk population.”

Ozempic’s journey began with its initial FDA approval in 2017 for blood sugar control in adults with type 2 diabetes, alongside diet and exercise. This was followed by a 2020 approval to reduce major cardiovascular events in type 2 diabetes patients with established heart disease. This latest FDA decision further expands Ozempic’s therapeutic reach, providing a vital treatment option to mitigate kidney disease progression, kidney failure, and cardiovascular death in adults with type 2 diabetes and CKD.

It is important to note that Novo Nordisk remains the sole manufacturer of FDA-approved semaglutide medications, including Ozempic®.

Understanding the FLOW Trial

FLOW was a comprehensive international study designed as a randomized, double-blind, placebo-controlled trial. It aimed to evaluate Ozempic® 1 mg against placebo, when added to standard care, on kidney outcomes in adults with type 2 diabetes and CKD. The primary endpoint was a composite measure of sustained decline in kidney function (eGFR), kidney failure, renal death, and cardiovascular death. The trial enrolled over 3,500 adults across 28 countries and approximately 400 sites. Remarkably, the study was halted early due to achieving pre-defined efficacy criteria after a median follow-up of 3.4 years, based on the recommendation of an Independent Data Monitoring Committee.

What is Ozempic®?

Ozempic® (semaglutide) injection is a prescription medication available in 0.5 mg, 1 mg, or 2 mg doses. It is indicated for:

• Improving blood sugar control in adults with type 2 diabetes, alongside diet and exercise.
• Reducing the risk of major cardiovascular events (heart attack, stroke, or death) in adults with type 2 diabetes and known heart disease.
• Reducing the risk of kidney disease worsening, kidney failure, and cardiovascular death in adults with type 2 diabetes and chronic kidney disease.

Ozempic®’s safety and effectiveness in children have not been established.

Important Safety Considerations

Crucial Warning: Never share your Ozempic® pen with others, even if the needle is changed. Sharing pens can transmit serious infections.

Key Safety Information Regarding Ozempic®:

• Potential Thyroid Tumors, Including Cancer: Seek immediate medical attention if you notice a lump or swelling in your neck, hoarseness, difficulty swallowing, or shortness of breath, as these could be symptoms of thyroid cancer. Animal studies have shown a link between Ozempic® and thyroid tumors, including thyroid cancer. The risk in humans is currently unknown.
• Contraindications: Avoid Ozempic® if you or your family has a history of medullary thyroid carcinoma (MTC) or if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not use if you are allergic to semaglutide or any of Ozempic’s ingredients.

Before starting Ozempic®, inform your healthcare provider if you have any pre-existing medical conditions, particularly:

• Pancreas issues.
• Diabetic retinopathy history.
• Severe stomach problems like gastroparesis or digestive issues.
• Scheduled surgery or procedures requiring anesthesia.
• Pregnancy, breastfeeding, or plans for pregnancy. Ozempic® should be discontinued at least 2 months before planned pregnancy.

Disclose all medications you are taking to your healthcare provider, including prescription, over-the-counter drugs, vitamins, herbal supplements, and diabetes medications, especially insulin or sulfonylureas.

Possible Side Effects of Ozempic®:

Ozempic® can cause serious side effects, including:

• Pancreatitis: Discontinue Ozempic® and seek immediate medical help if you experience severe, persistent abdominal pain, with or without vomiting.
• Vision Changes: Report any vision changes to your doctor.
• Hypoglycemia (Low Blood Sugar): The risk is higher when used with sulfonylureas or insulin. Be aware of hypoglycemia symptoms such as dizziness, blurred vision, anxiety, sweating, confusion, and rapid heartbeat.
• Dehydration and Kidney Problems: Severe diarrhea, nausea, and vomiting can lead to dehydration, potentially causing kidney issues. Maintain adequate fluid intake and report persistent nausea, vomiting, or diarrhea.
• Severe Stomach Problems: Report severe or persistent stomach issues.
• Severe Allergic Reactions: Discontinue Ozempic® and seek immediate medical help for symptoms like swelling, breathing difficulties, severe rash, dizziness, or rapid heartbeat.
• Gallbladder Problems: Symptoms may include upper abdominal pain, fever, jaundice, or clay-colored stools. Report these to your doctor.
• Risk of Aspiration During Procedures: Ozempic® may increase the risk of aspiration during surgery or procedures with anesthesia. Inform all healthcare providers about Ozempic® use before any procedure.

Common side effects may include nausea, vomiting, diarrhea, abdominal pain, and constipation.

About Novo Nordisk

Novo Nordisk is a global leader in healthcare, dedicated to innovation in diabetes care for over a century. Building on this legacy, Novo Nordisk is committed to driving change in other serious chronic diseases, including obesity, rare blood disorders, and endocrine conditions. With a strong commitment to responsible business practices, Novo Nordisk operates with a long-term perspective, focused on financial, social, and environmental responsibility. Novo Nordisk employs approximately 8,000 people in the U.S. For further information, please visit novonordisk-us.com and connect on social media: Facebook, Instagram, and X.

Novo Nordisk emphasizes the responsible use of semaglutide medications, recognizing that different products have distinct indications, dosages, and delivery methods. These products are not interchangeable and should only be used within their approved indications.

This information is intended for US media audiences only.

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References

1. Ozempic® (semaglutide) injection [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2024.
2. Feng X (Snow), Farej R, Dean BB, et al. CKD prevalence among patients with and without type 2 diabetes: regional differences in the United States. Kidney Medicine. 2022;4(1):100385. doi:https://doi.org/10.1016/j.xkme.2021.09.003.
3. National Kidney Foundation. Diabetes and chronic kidney disease. Last accessed: January 2025. Available at: https://www.kidney.org/diabetes-and-chronic-kidney-disease
4. Von Scholten BJ, Kreiner FF, Rasmussen S, Rossing P, Idorn T. (2022). The potential of GLP-1 receptor agonists in type 2 diabetes and chronic kidney disease: from randomised trials to clinical practice. Ther Adv Endocrinol Metab. 2022; 13, 20420188221112490. https://doi.org/10.1177/20420188221112490.
5. Afkarian M, Sachs MC, Kestenbaum B, Hirsch IB, Tuttle KR, Himmelfarb J, de Boer IH. Kidney disease and increased mortality risk in type 2 diabetes. J Am Soc Nephrol. 2013 Feb;24(2):302-8. doi: 10.1681/ASN.2012070718. Epub 2013 Jan 29. PMID: 23362314; PMCID: PMC3559486.
6. Perkovic V, Tuttle KR, Rossing P, et al. Effects of semaglutide on chronic kidney disease in patients with type 2 diabetes. NEJM. 2024. https://doi.org/10.1056/nejmoa2403347.

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