Novo Nordisk released data from a late-stage clinical trial that indicated semaglutide — better known by its brand name Ozempic — reduced the risk of death in diabetes patients with chronic kidney disease (CKD).
Published in the New England Journal of Medicine on Friday morning, the multi-year study determined that the risk of a primary-outcome event — such as major kidney disease events, kidney failure or death — was 24% lower in the group that received Ozempic than participants in the placebo group.
Novo stated that the trial met its secondary endpoints, including a less steep mean annual estimated glomerular filtration rate as well as a lower risk of major adverse cardiovascular events (MACE) and risk of death from any cause.
Additionally, a lower percentage of serious adverse events were reported in the semaglutide group than the placebo group. More detailed data from the study was presented at the European Renal Association meeting in Stockholm.
This trial represents the promise of potential label expansion that Ozempic, which is indicated for treating type 2 diabetes, and other GLP-1 drugs could have beyond treating diabetes and obesity.
While GLP-1 drugs have taken off in popularity due to widespread off-label use for weight loss — which has caused rampant, lingering shortages — both Novo and rival Eli Lilly have been studying this class’ potential use in other therapeutic areas.
Thus far, the results have been encouraging and led to substantive insurance coverage changes.
Last August, Novo announced that its once-weekly semaglutide 2.4 mg treatment for obesity — known by the brand name Wegovy — cut the risk of MACE by 20% in a clinical trial. A study released a few weeks later reiterated that semaglutide treatment led to “large reductions” in heart failure-related symptoms for adults with the condition and obesity.
Based on these clinical trials, the Food and Drug Administration approved a label expansion for Wegovy to be used as a treatment in heart disease this spring. One week after that, the Centers for Medicare and Medicaid Services announced that Medicare Part D plans could cover anti-obesity drugs like Wegovy.
Ozempic and Wegovy have also served as financial juggernauts for the Danish drugmaker, which saw sales rise 24% in Q1, thanks to diabetes and obesity care sales jumping 27% and GLP-1 diabetes products contributing 32% sales growth.
While Novo’s stock was trading down slightly after the study’s release, it served as a boon for dialysis providers like Fresenius, DaVita and FMC.
