Ozempic, a GLP-1 drug, Receives FDA Approval for Reducing Risks of Chronic Kidney Disease
The US Food and Drug Administration has approved Ozempic, a medication originally designed to treat type 2 diabetes, to reduce certain risks associated with chronic kidney disease. A Phase 3 clinical trial found that injecting the semaglutide medication once weekly reduced the risk of kidney disease worsening by 24% in individuals with type 2 diabetes. Additionally, the medication reduced the risk of kidney failure and cut the risk of death from heart disease by about 5% in adults with both type 2 diabetes and chronic kidney disease.
Chronic kidney disease is a common complication for people living with type 2 diabetes, with about a third of adults with diabetes also having the condition. The clinical trial tested the efficacy of Ozempic when added to standard treatment, rather than as a replacement for other treatments.
The new indications approved by the FDA make Ozempic the most broadly indicated drug in its class, with the largest set of specific medical conditions that it may be prescribed to treat. Novo Nordisk, the manufacturer, is conducting further research to understand the mechanisms behind the positive effects of semaglutide on kidney disease progression.
The positive results of the clinical study, which was stopped early due to reaching positive endpoints sooner than expected, have significant implications for patients. The medicine has the potential to reduce the risk of kidney failure, heart disease, and all-cause death.
Despite the short supply of Ozempic and other semaglutide injections, the FDA has listed Ozempic as “available”, and the manufacturer hopes that the confidence in the data behind the approval will aid clinicians in their decision-making process and focus treatment on patients who will benefit the most.