
Novo Nordisk’s Ozempic has secured FDA approval, opening a promising avenue for treating chronic kidney disease in type 2 diabetes patients.
Quick Takes
- Ozempic receives FDA approval for chronic kidney disease management in type 2 diabetes patients.
- The therapy shows a 24% reduction in the risk of major complications and death from cardiovascular disease.
- Chronic kidney disease affects about 37 million adults in the U.S., with a high prevalence among type 2 diabetes patients.
- The approval marks the first GLP-1 therapy authorized for kidney disease in type 2 diabetes.
FDA Greenlights Ozempic
The FDA has approved Novo Nordisk’s Ozempic (semaglutide) to manage chronic kidney disease in adults with type 2 diabetes. This decision aims to reduce the risk of kidney disease worsening, kidney failure, and cardiovascular-related death. As the first GLP-1 therapy for chronic kidney disease, this marks a major advance in the management of these patients. The approval is based on the promising results from the FLOW phase 3b trial, emphasizing its potential to revolutionize treatment options.
Chronic kidney disease is a serious concern for those with type 2 diabetes, affecting around 37 million American adults. It often coexists with diabetes, with 40% of type 2 patients experiencing chronic kidney complications. Ozempic promises a glimmer of hope for these individuals, offering a targeted solution that addresses multiple health burdens.
FDA Approves Ozempic (semaglutide) as the Only GLP-1 RA to Reduce the Risk of Worsening Kidney Disease and Cardiovascular Death in Adults with Type 2 Diabetes and Chronic Kidney Disease https://t.co/GY72OjRdtW
— Drugs.com (@Drugscom) January 28, 2025
Trial Results and Implications
The approval draws on data from the FLOW trial, involving approximately 3,500 patients with diabetes and moderate to severe kidney disease. Results indicated a 24% reduction in the risk of kidney and cardiovascular events compared to a placebo. While gastrointestinal issues led to some discontinuation in the semaglutide group, serious adverse events were comparatively low. Such findings could potentially shift how chronic kidney disease is managed in the diabetes community.
“Type 2 diabetes can be challenging enough to manage without the added risk of chronic kidney disease, and I have seen in my own practice that patients with type 2 diabetes and chronic kidney disease need extra support from medications that may have a profound clinical impact by lowering the risk of major kidney and cardiovascular outcomes,” said Richard E. Pratley, M.D.
Alongside its promise, Ozempic is notably priced at $997.58 per pen. However, there are provisions for copay assistance for those with commercial insurance, a crucial consideration for those facing drug affordability challenges. Furthermore, the drug is included in Medicare Part D price negotiations, highlighted by recent legislative changes under the Inflation Reduction Act.
👍👍👍👍👍 https://t.co/WdtKHrGba1
— Bologna Fish, M.D. (@BolognaFishMD) January 28, 2025
Global and Economic Impact
This recent development isn’t confined to the U.S. alone; EU regulators also approved Ozempic back in December for the same condition. This sets a global precedent and a key victory for Novo Nordisk, especially in the face of competitive pressures from other pharmaceutical companies like Eli Lilly. The rapid endorsement of POSITIVE RESULTS has even affected shares of kidney dialysis companies, further underlining the wide-reaching influence of this breakthrough.
Amidst these health advancements, Novo Nordisk is pushing to expand coverage for Wegovy, another of its innovations. A major coalition advocates incorporating FDA-approved obesity medications into Medicare and Medicaid. Such moves could significantly broaden access to life-changing treatment solutions, benefiting millions more Americans.