The approval continues the trend of GLP-1s expanding to indications outside of diabetes and weight loss.
Novo Nordisk’s blockbuster GLP-1 drug Ozempic has nabbed yet another label expansion outside of its original field, with the FDA granting approval for its use in chronic kidney disease.
Tuesday’s regulatory verdict, specifically for Ozempic’s use to reduce the risk of kidney disease worsening, kidney failure, and death from cardiovascular disease in adults with type 2 diabetes and chronic kidney disease, makes Ozempic the “most broadly indicated” therapy in its class, according to a statement released by Novo.
The GLP-1 was originally approved for glycemic control in type 2 diabetes (T2D) in 2017. Three years later, Ozempic got the FDA’s greenlight for lowering the risk of major adverse cardiovascular events in adults with T2D and established cardiovascular disease. The drug, called semaglutide, continued to expand into weight loss as Wegovy in 2021, and last year Wegovy notched an approval for the reduction of cardiovascular risk.
“This approval for Ozempic allows us to more broadly address conditions within cardiovascular-kidney-metabolic syndrome,” Anna Windle, senior vice president of Clinical Development, Medical & Regulatory Affairs at Novo, said in a statement. The FDA greenlight follows a similar approval from the European Medicines Agency (EMA) in December 2024.
Rival GLP-1 maker Eli Lilly is similarly looking to push its tirzepatide, approved for T2D in 2021 as Mounjaro and in late 2023 as Zepbound for weight loss. Last month, the FDA approved Zepbound as the first ever drug for obstructive sleep apnea. And these two weight loss leaders aren’t the only ones going after other indications for GLP-1s.
Ozempic’s label expansion into kidney disease was backed by data from the Phase IIIb FLOW trial, which according to a March 2024 readout showed a 24% reduction in the risk of kidney disease progression, kidney death and major adverse cardiovascular events, as compared with placebo.
In a note to investors, analysts at BMO Capital Markets called the label expansion a “positive” for Novo, although one that “likely represents more limited commercial upside.”
The BMO analysts noted that Ozempic’s expansion “adds to the mounting body of evidence showing GLP-1 agents’ utility in indications beyond T2D and obesity.”
The label expansion for Ozempic could also help Novo keep ahead in an increasingly competitive obesity market, which in recent days has seen a flurry of clinical activity.
On Monday, Veru Inc. posted topline Phase IIb data for its investigational selective androgen receptor modulator, touting a 71% drop in the loss of lean mass in seniors taking Wegovy. The same day, up-and-coming obesity player Metsera unveiled a $250 million IPO,eyeing a $1.78 billon company valuation. Then on Tuesday, Versant Ventures launched Helicore Biopharma—the investor’s fourth obesity-focused biotech in a year and the second new company in the space this month alone.
