Initial late-stage study data announced on Tuesday showed that Novo Nordisk’s popular medicine Ozempic reduced the risk of kidney disease development and related health consequences in diabetic individuals.
However, investors were unsatisfied with Novo’s headline results from the phase 3 FLOW research on Tuesday, as the price of the Danish company’s shares fell 3%. These are the irrational hopes for the blockbuster medication that lowers blood sugar.
In patients with type 2 diabetes and chronic kidney disease (CKD), the double-blind trial compared injectable semaglutide 1.0 mg with placebo as an adjuvant to a standard of treatment for preventing the development of renal impairment and risk of kidney and cardiovascular death. 3,533 patients with CKD and type 2 diabetes were included in the experiment.
By showing a statistically significant and better reduction in the development of renal disease, major adverse cardiovascular events (MACE), and mortality of 24% for patients treated with semaglutide 1.0 mg compared to placebo1, the trial met its primary aim.
Five components that measured the course of CKD and the risk of renal and cardiovascular death were included in the composite main endpoint. The main endpoint’s cardiovascular and CKD components both helped to lower the risk. Additionally, it was established that semaglutide 1 mg was superior to a placebo for the confirmatory secondary endpoints.
In 2024, the business intends to apply for regulatory approval of a label extension for Ozempic in the United States and the European Union. It also plans to present comprehensive findings from Flow at a scientific conference.
“Importantly these results do not expand the addressable GLP-1 population, but do strengthen the case for greater GLP-1 use in Type 2 diabetes as per our market model,” the analysts wrote.