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New drug application submitted for semaglutide for type 2 diabetes treatment
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A new drug application was submitted to the FDA for the once-weekly glucagon-like peptide-1 analogue semaglutide for treatment in adults with type 2 diabetes, according to a press release from Novo Nordisk.
Semaglutide, in combination with oral antidiabetic agents and basal insulin, achieved statistically significant and sustained blood glucose control compared with the DPP-IV inhibitor sitagliptin (Januvia, Merck), the GLP-1 receptor agonist exenatide extended-release (Byetta, AstraZeneca), once-daily insulin glargine U100 and placebo during the SUSTAIN clinical trial program. Further, reductions in weight and cardiovascular risk were also achieved with semaglutide.
The most common reported adverse events were nausea, vomiting, diarrhea, abdominal pain and constipation.
“Achieving blood glucose control, weight loss and reducing the risk of cardiovascular events remains a significant challenge for adults with type 2 diabetes,” Mads Krogsgaards Thomsen, executive vice president and chief science officer for Novo Nordisk, said in the release. “We are excited with this regulatory filing as results from the SUSTAIN program show that once-weekly semaglutide has the potential to offer further improvement for adults in their treatment of type 2 diabetes.”
Novo Nordisk also submitted a marketing authorization application for semaglutide to the European Medicines Agency.