When Novo Nordisk unveiled kidney outcomes data for its star GLP-1 medicine Ozempic last May, the company’s executive medical director suggested the results could help set a new standard for “holistic” care for many diabetes patients.
Now, the FDA appears to have bought in, too.
The FDA on Tuesday gave Ozempic a thumbs-up to reduce the risk of kidney disease worsening, kidney failure and death from cardiovascular disease in adult Type 2 diabetes patients who also have chronic kidney disease (CKD).
The CKD approval—which is a first among GLP-1 receptor agonists—makes Ozempic the most broadly indicated drug among its class, Novo pointed out in a press release.
The semaglutide-based medicine was originally approved for Type 2 diabetes in 2017 before picking up a subsequent nod to curb the risk of major cardiovascular events in diabetes patients in 2020.
Novo estimates that CKD affects some 37 million adults in the U.S., with that number likely to rise in the coming years. The condition is also a common complication of Type 2 diabetes, cropping up in around 40% of patients living with the chronic metabolic disease.
“Type 2 diabetes doesn’t exist in a vacuum,” Michael Radin, M.D., Novo’s executive medical director, said of the Ozempic kidney data during an interview last year. “These patients often have concomitant cardiovascular disease, they have chronic kidney disease, and there’s a move in the medical community to be able to treat these patients holistically.”
The FDA granted its approval after reviewing data from Ozempic’s phase 3b FLOW kidney outcomes trial, which found the Novo drug plus standard of care helped curb the risk of kidney disease worsening, kidney failure and death from cardiovascular disease by 24% compared with placebo.
Beyond that primary endpoint, Ozempic also cut the risk of major cardiovascular events by 18% and reduced the risk of all-cause mortality by 20%, Novo revealed in a detailed data drop last May.
Novo’s latest approval comes as the company’s semaglutide franchise—covering both Ozempic and Rybelsus in diabetes and Wegovy in obesity—continues to thrive.
Aside from raking in billions of dollars in annual sales, Ozempic and Wegovy—which garnered immense mainstream popularity thanks to their ability to help patients lose weight—have largely escaped a supply squeeze that’s been plaguing both products for years.
Meanwhile, Novo isn’t content to rest on its laurels as it tests semaglutide in a range of other indications like metabolic dysfunction-associated steatohepatitis, heart failure and even Alzheimer’s disease.