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Novo Nordisk Files for Regulatory Approval of Once-Weekly Semaglutide for Type-2 Diabetes
Novo Nordisk has submitted a new drug application to the FDA for semaglutide, a glucagon-like peptide-1 (GLP-1) analogue administered once weekly for the treatment of adults with type-2 diabetes (T2D). The submission was based on results from the SUSTAIN clinical trial program, which included eight phase 3a studies involving more than 8,000 adults with T2D.
In the SUSTAIN program, once-weekly semaglutide was administered in combination with oral antidiabetic agents and basal insulin. Semaglutide demonstrated statistically significant and sustained blood glucose control compared with that of sitagliptin, extended-release exenatide, once-daily insulin glargine U100, and placebo. In addition, semaglutide was associated with significantly greater reductions in mean body weight compared with the comparators.
Across the SUSTAIN clinical trial program, once-weekly semaglutide was safe and well tolerated, with the most common adverse event being nausea.
In September, Novo Nordisk reported that once-weekly semaglutide had reduced the primary composite endpoint of the time to the first occurrence of either cardiovascular (CV) death, nonfatal myocardial infarction (MI), or nonfatal stroke by 26% compared with placebo when added to standard of care in 3,297 adults with T2D at high CV risk. These results were based on an accumulation of first major adverse CV events in 254 subjects.
In addition, semaglutide was associated with a significant 39% reduction in nonfatal stroke, a nonsignificant 26% reduction in nonfatal MI, and a neutral outcome (a 2% decrease) in CV death after two years of treatment.
Semaglutide stimulates insulin and suppresses glucagon secretion in a glucose-dependent manner while reducing appetite and food intake. If approved, once-weekly semaglutide will be available in a prefilled delivery device.