Novo Nordisk announced that the European Medicines Agency (EMA) has adopted a positive opinion on an update to the Ozempic (semaglutide) label to reflect risk reduction of kidney disease-related events.
The update reflects data from the FLOW kidney outcomes trial, whose results were announced in March this year.
Ozempic is an adjunct to diet and exercise for improving glycaemic control in adults with type 2 diabetes and reducing the risk of major cardiovascular events in adults with type 2 diabetes and established cardiovascular disease.
The randomised, double-blinded, parallel-grouped, placebo-controlled, superiority FLOW trial evaluated the impact of Ozempic (semaglutide) on reducing chronic kidney disease (CKD) events.
The study, started in 2019, enrolled a total of 3,533 individuals from 400 investigator sites in 28 countries.
In October 2023, Novo Nordisk decided to halt the trial early due to its positive efficacy, following a recommendation from an Independent Data Monitoring Committee.
According to the results, semaglutide 1.0 mg showed a 24% significant and superior risk reduction in kidney disease progression, as well as in cardiovascular and kidney-related deaths compared to placebo.
Secondary endpoints also demonstrated an 18% reduction in major cardiovascular events and a 20% decrease in all-cause mortality.
Novo Nordisk development executive vice president Martin Lange said: “Approximately 40% of people with type 2 diabetes develop chronic kidney disease, and there is a need for treatments that can help to reduce kidney disease progression.
“With this positive opinion, Ozempic will become the first and only GLP-1 receptor agonist to show lowering of risk of kidney disease progression in adults with type 2 diabetes and chronic kidney disease.”
The Danish pharmaceutical company has filed for a label expansion of Ozempic in the US, with a decision expected in the first half of 2025.
In October this year, Novo Nordisk and Mylan Pharmaceuticals, a unit of Viatris, settled their patent dispute and validity challenge over Ozempic and Wegovy.
In a lawsuit, Novo Nordisk accused Mylan Pharmaceuticals of patent infringement while developing a generic version of Ozempic.
