Danish pharmaceutical company Novo Nordisk has reported full results from the Phase III FLOW clinical trial of Ozempic (semaglutide) in adult subjects with type 2 diabetes and chronic kidney disease.
Patients in the trial who were given 1mg of semaglutide once a week showed a significant decrease in the risk of major kidney disease events, which was the trial’s primary endpoint.
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These events were defined as a composite of kidney failure, a sustained drop of 50% or more in estimated glomerular filtration rate (eGFR) from baseline, or death due to kidney-related or cardiovascular causes.
A 24% risk reduction in kidney disease progression and mortality was observed in the semaglutide arm when compared with placebo.
The semaglutide treatment was also superior to placebo in all confirmatory secondary outcomes, including reducing the mean annual eGFR slope by 1.16 ml/min or 1.73 m²/year.
Novo Nordisk presented these results at the American Diabetes Association’s 84th Annual Scientific Sessions.
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By GlobalDataThe company has submitted a label extension application for Ozempic to the US Food and Drug Administration, which is currently under review with a decision expected in January next year.
Novo Nordisk Medical & Regulatory Affairs clinical development senior vice-president Anna Windle said: “The results from the FLOW trial represent important data, as we look to better understand what GLP-1 treatment options could mean for this patient population.
“Leveraging our deep expertise in cardiometabolic science, we are proud to continue building strong clinical evidence on the strength and versatility of semaglutide to deliver results for people living with serious chronic diseases.”
Last month, Novo Nordisk reported results from the Phase IIIa FRONTIER II trial of subcutaneous Mim8 in treating haemophilia A.
Both tested doses of Mim8 resulted in a statistically significant decline in treated bleeding episodes compared with no prophylaxis and prior coagulation factor prophylaxis therapy.
