GLP-1 medication are being studied in a rising variety of indications, and Novo Nordisk can now declare to have the primary remedy on this class permitted for power kidney illness.
The FDA has expanded the label of Ozempic, approving the Novo Nordisk product for decreasing the danger of worsening kidney illness and kidney failure in addition to decreasing the danger of demise. The brand new approval introduced Tuesday covers use of the drug in sufferers who’ve each sort 2 diabetes and power kidney illness. Sort 2 diabetes is a danger issue for creating power kidney illness.
The principle pharmaceutical ingredient in Ozempic is semaglutide, a peptide engineered to imitate the GLP-1 hormone in our our bodies. This drug binds to and prompts the GLP-1 receptor to set off metabolic results. Ozempic was initially permitted in 2017 for the administration of blood glucose in sufferers with sort 2 diabetes. Three years later, the FDA expanded the product’s approval to incorporate decreasing the danger of main cardiovascular occasions — coronary heart assault, stroke, or demise — in adults with sort 2 diabetes and identified coronary heart illness.
The newest Ozempic approval is predicated on the outcomes of a placebo-controlled Part 3 scientific trial that evaluated the drug in adults with sort 2 diabetes and power kidney illness. The principle purpose was a composite endpoint comprised of 5 measures of kidney well being. An interim take a look at the info confirmed the drug was so profitable on these measures that Novo Nordisk was in a position to cease the research early. When the outcomes lastly got here out, they revealed the once-weekly injection decreased the danger of kidney illness problems by 24% in comparison with a placebo, which was statistically vital.
An estimated 37 million adults within the U.S. have power kidney illness, in accordance with Novo Nordisk. That quantity is anticipated to rise with an growing old inhabitants and the rising prevalence of diabetes.
“This approval for Ozempic permits us to extra broadly deal with circumstances inside cardiovascular-kidney-metabolic syndrome, which impacts tens of millions of adults and will have critical penalties if left untreated,” Anna Windle, senior vice chairman scientific improvement, medical & regulatory affairs at Novo Nordisk, stated in a ready assertion. “With this new indication, Ozempic stands out uniquely as essentially the most broadly indicated GLP-1 [receptor agonist] in its class.”
Wegovy, the blockbuster Novo Nordisk weight problems drug, additionally accommodates semaglutide as the primary ingredient, however at completely different doses than Ozempic. Final March, the FDA expanded Wegovy’s approval to incorporate decreasing cardiovascular dangers in adults with heart problems and both weight problems or obese. The corporate can also be looking for to develop Wegovy’s label to incorporate the fatty liver illness metabolic dysfunction-associated steatohepatitis (MASH). Eli Lilly, the Danish firm’s essential metabolic medicines rival, can also be looking for to develop the permitted makes use of of its GLP-1 and GIP receptor agonist weight problems drug, Zepbound. In late 2024, the FDA permitted Zepbound as a remedy for obstructive sleep apnea.
Ozempic is Novo Nordisk’s top-selling product, accounting for 86.4 billion Danish krone (about $12 billion) in income within the first 9 months of 2024. The overwhelming majority of these gross sales had been in North America, in accordance with the corporate’s monetary stories.
The newest FDA approval expands the marketplace for Ozempic even because the product faces coming pricing challenges. Ozempic, Rybelsus, and Wegovy — all of which include semaglutide as the primary ingredient — are among the many 15 medication chosen for worth negotiation with the Facilities for Medicare & Medicaid Providers. Novo Nordisk objects to the grouping of a number of merchandise it contends wouldn’t meet the legislation’s necessities if thought-about individually. However federal officers stated that number of a drug for worth negotiation beneath the legislation covers all dosage types and strengths of a pharmaceutical ingredient, even when that ingredient is marketed beneath completely different model names. Negotiated costs for this group of medicine would take impact in 2027.
Photograph by Novo Nordisk