{"id":631235,"date":"2025-01-31T16:33:06","date_gmt":"2025-01-31T21:33:06","guid":{"rendered":"https:\/\/www.singlecare.com\/blog\/?p=631235"},"modified":"2025-01-31T16:33:06","modified_gmt":"2025-01-31T21:33:06","slug":"ozempic-kidney-disease-fda-approval","status":"publish","type":"post","link":"https:\/\/www.singlecare.com\/blog\/news\/ozempic-kidney-disease-fda-approval\/","title":{"rendered":"FDA approves Ozempic for kidney disease"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">The blockbuster GLP-1 drug <\/span><a href=\"https:\/\/www.singlecare.com\/prescription\/ozempic\"><span style=\"font-weight: 400;\">Ozempic<\/span><\/a><span style=\"font-weight: 400;\"> has received approval for yet another chronic medical condition. The U.S. Food and Drug Administration (FDA) expanded Ozempic\u2019s indication to reduce the risk of kidney disease worsening, kidney failure, and death due to cardiovascular disease in adults with Type 2 diabetes and <\/span><a href=\"https:\/\/www.singlecare.com\/blog\/chronic-kidney-disease\/\"><span style=\"font-weight: 400;\">chronic kidney disease<\/span><\/a><span style=\"font-weight: 400;\"> (CKD).\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u201cChronic 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,&#8221; said Anna Windle, Ph.D., Senior Vice President of Clinical Development, Medical &amp; Regulatory Affairs at Novo Nordisk in a statement.\u00a0<\/span><\/p>\n<h2 id=\"what-is-ozempic\"><span style=\"font-weight: 400;\">What is Ozempic?<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">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 (<\/span><a href=\"https:\/\/www.singlecare.com\/prescription\/diabetes-test-hba1c\"><span style=\"font-weight: 400;\">HbA1c<\/span><\/a><span style=\"font-weight: 400;\">), a blood test that shows average blood sugar levels over a three-month period.\u00a0<\/span><\/p>\n<p><a href=\"https:\/\/www.singlecare.com\/blog\/how-to-use-ozempic-pen\/\"><span style=\"font-weight: 400;\">Ozempic injections<\/span><\/a><span style=\"font-weight: 400;\"> 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\u2019s 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.\u00a0<\/span><\/p>\n<h2 id=\"benefits-for-people-with-kidney-disease\"><span style=\"font-weight: 400;\">Benefits for people with kidney disease<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">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 <\/span><a href=\"https:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa2403347\"><span style=\"font-weight: 400;\">study<\/span><\/a><span style=\"font-weight: 400;\"> in the <\/span><i><span style=\"font-weight: 400;\">New England Journal of Medicine<\/span><\/i><span style=\"font-weight: 400;\"> noted.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">CKD is a common complication of diabetes\u201437 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.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">According to the National Kidney Foundation, <\/span><a href=\"https:\/\/www.kidney.org\/kidney-topics\/chronic-kidney-disease-ckd\"><span style=\"font-weight: 400;\">risk factors for chronic kidney disease<\/span><\/a><span style=\"font-weight: 400;\"> include:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Diabetes<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Obesity<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Hypertension (high blood pressure)<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Heart failure<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Heart disease<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Increasing age (older than age 60)<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Family history of CKD or kidney failure<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">History of smoking or tobacco use<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Personal history of acute kidney injury<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">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.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">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 \u201ca 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.\u201d In other words, it was very effective at preventing CKD from worsening.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">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.<\/span><\/p>\n<h2 id=\"other-approved-uses-of-semaglutide\"><span style=\"font-weight: 400;\">Other approved uses of semaglutide<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">This is not the first time that the FDA has expanded the use of semaglutide.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">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.\u00a0<\/span><\/p>\n<h3 id=\"heart-disease\"><span style=\"font-weight: 400;\">Heart disease<\/span><\/h3>\n<p><span style=\"font-weight: 400;\">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, <\/span><a href=\"https:\/\/www.novonordisk-us.com\/media\/news-archive\/news-details.html?id=915253\"><span style=\"font-weight: 400;\">the FDA expanded the use of Ozempic<\/span><\/a><span style=\"font-weight: 400;\"> in 2020 to reduce the risk of heart attack, stroke, or death in adults with Type 2 diabetes with known heart disease.<\/span><\/p>\n<h3 id=\"weight-loss\"><span style=\"font-weight: 400;\">Weight loss<\/span><\/h3>\n<p><span style=\"font-weight: 400;\">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, <\/span><a href=\"https:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa2032183\"><span style=\"font-weight: 400;\">in one clinical trial<\/span><\/a><span style=\"font-weight: 400;\">, 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<\/span><a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-approves-new-drug-treatment-chronic-weight-management-first-2014\"><span style=\"font-weight: 400;\"> FDA to approve Wegovy<\/span><\/a><span style=\"font-weight: 400;\"> (semaglutide) in 2021 specifically for weight loss in adults who are obese or overweight and have at least one weight-related medical condition.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">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.\u00a0<\/span><\/p>\n<h2 id=\"what-s-next\"><span style=\"font-weight: 400;\">What\u2019s next?<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">As research continues, Ozempic\u2013and other GLP-1s\u2014may be approved for even more uses. For example, a new <\/span><a href=\"https:\/\/www.nature.com\/articles\/s41591-024-03412-w\"><span style=\"font-weight: 400;\">study<\/span><\/a><span style=\"font-weight: 400;\"> published in the journal <\/span><i><span style=\"font-weight: 400;\">Nature Medicine<\/span><\/i><span style=\"font-weight: 400;\"> 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 <\/span><a href=\"https:\/\/www.singlecare.com\/prescription\/zepbound\"><span style=\"font-weight: 400;\">Zepbound<\/span><\/a><span style=\"font-weight: 400;\"> (tirzepatide) for the <\/span><a href=\"https:\/\/www.singlecare.com\/blog\/news\/zepbound-sleep-apnea-fda-approval\/\"><span style=\"font-weight: 400;\">treatment of obstructive sleep apnea<\/span><\/a><span style=\"font-weight: 400;\">, a condition common among obese or overweight people. Previously, Zepbound was only <\/span><a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-approves-new-medication-chronic-weight-management\"><span style=\"font-weight: 400;\">approved for chronic weight management<\/span><\/a><span style=\"font-weight: 400;\">.\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>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\u2019s 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).\u00a0 \u201cChronic kidney disease is [&hellip;]<\/p>\n","protected":false},"author":85,"featured_media":631236,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[4114],"tags":[10298,21067,9825],"coauthors":[9482],"class_list":["post-631235","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-diabetes","tag-glp-1-drugs","tag-weight-loss","wpautop"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.4 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Ozempic approved for kidney disease<\/title>\n<meta name=\"description\" content=\"The FDA has approved Ozempic to slow the progression of kidney disease. 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