Dive Brief:

• Novo Nordisk on Tuesday won an expanded approval for Ozempic, allowing the company to market its top-selling medicine to reduce the risk of kidney complications in adults with type 2 diabetes and chronic kidney disease.
• Ozempic is the first GLP-1 drug to win Food and Drug Administration approval for use protecting kidney health. The FDA acted based on a study showing Ozempic could reduce the risk of worsening kidney disease, kidney failure and death due to cardiovascular disease. The effects were so pronounced that Novo halted the trial early in 2023.
• The new indication adds to a growing list of uses for Ozempic, first approved in 2017 to improve blood sugar in patients with type 2 diabetes. The FDA has also cleared Ozempic to reduce the risk of major cardiovascular events in diabetes patients with heart disease. And a different formulation of the drug — sold as Wegovy — is cleared to treat obesity and protect heart health.

Dive Insight:

The approval, on the heels of encouraging results for a next-generation obesity medicine, offers another much-needed piece of good news during a period of struggle for the Danish drugmaker.

Over the last two months, Novo learned that Eli Lilly’s rival obesity drug Zepbound bested its own Wegovy in a head-to-head trial, announced study results for a newer weight-loss drug that missed expectations and was informed that Medicare will include Ozempic/Wegovy in its next round of price negotiations. Novo shares, which soared above $148 in June, traded at about $85 apiece midday Wednesday.

Meanwhile, Lilly this month reported fourth-quarter sales for its GLP-1 medicines that fell below analyst expectations, sparking questions about the long-term market. And a recent study found that patients without diabetes often quit taking GLP-1 drugs for obesity within a year.

Still, the approval supporting Ozempic’s protective kidney effects is one of many that show promise for the GLP-1 drugs. Based on a successful Phase 3 trial, Novo aims to market a version of Ozempic to treat a common liver disease known as metabolic dysfunction-associated steatohepatitis. Lilly’s Zepbound recently won approval to treat obstructive sleep apnea. And researchers are even seeing promise for the GLP-1 medicines in Alzheimer’s disease.

With the new approval for diabetes patients with kidney disease, “Ozempic stands out uniquely as the most broadly indicated GLP-1” in its class, Anna Windle, Novo’s senior vice president for clinical development, medical and regulatory affairs, said in the company’s statement.