Ozempic, the popular GLP-1 medication originally authorized for type 2 diabetes treatment, has now received approval from the US Food and Drug Administration (FDA) to address certain risks linked to chronic kidney disease, according to drugmaker Novo Nordisk.

A Phase 3 clinical trial revealed that weekly injections of the semaglutide drug reduced the risk of worsening kidney disease by 24% in diabetic patients. It also lowered the chances of kidney failure and decreased the risk of death from heart disease by approximately 5% in adults suffering from both type 2 diabetes and chronic kidney disease, as stated in a company press release. Chronic kidney disease is a frequent complication in people with type 2 diabetes, which is the leading cause of kidney failure — one of the top causes of death in the US and worldwide. About one-third of adults with diabetes are also affected by chronic kidney disease, according to the US Centers for Disease Control and Prevention.

The clinical trial evaluated Ozempic’s effectiveness as an addition to standard treatment, not as a replacement for other disease management medications such as blood pressure drugs like ACE inhibitors and ARBs. Around 3,500 adults from 28 countries participated in the trial, which began in 2019 and followed participants for an average of 3½ years.

The new FDA-approved indications now make Ozempic the most widely approved drug in its class, with the broadest range of conditions it can treat.

Novo Nordisk is conducting further research to explore how semaglutide reduces kidney disease progression. Despite the underlying mechanisms remaining unclear, the positive outcomes are undeniable: The clinical study ended early after achieving significant results ahead of schedule, with no new safety risks identified, according to Stephen Gough, global chief medical officer and senior vice president at Novo Nordisk.

"This has a meaningful impact on patients," said Gough, emphasizing the drug’s benefits not only for kidney disease but also for cardiovascular conditions and overall mortality.

Ozempic and other semaglutide medications, like Wegovy, have faced supply shortages due to high demand. While the FDA now lists Ozempic as “available,” demand remains strong.

“This is a medication already accessible in diabetes and renal clinics, and we expect the uptake to be swift,” Gough remarked, adding that the confidence brought by the approval data would assist clinicians in making informed decisions regarding treatment options.

“It aids clinicians in focusing treatments on patients who stand to benefit the most,” he concluded.