T2DM Drug Semaglutide Gets Closer to Approval with NDA Submission

The submission is based on results from the SUSTAIN clinical trial program, which included over 8,000 patients
The submission is based on results from the SUSTAIN clinical trial program, which included over 8,000 patients

Novo Nordisk has announced the submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for semaglutide, for the treatment of adults with type 2 diabetes

Semaglutide is a once-weekly administered analog of human glucagon-like peptide-1 (GLP-1) that stimulates insulin and suppresses glucagon secretion in a glucose-dependent manner.  

The submission is based on results from the SUSTAIN clinical trial program, which included over 8,000 patients with type 2 diabetes and was comprised of eight Phase 3a studies. Once-weekly semaglutide was assessed in combination with oral antidiabetic agents and in combination with basal insulin. When compared to sitagliptin, exenatide extended-release, once-daily insulin glargine U100 and placebo, semaglutide demonstrated statistically significant and sustained blood glucose control.  

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The secondary endpoint of the trial was weight loss, which was demonstrated in all semaglutide arms of the program. In addition, the cardiovascular outcomes trial showed cardiovascular risk reduction, when semaglutide was added to standard of care in patients with high cardiovascular risk compared to placebo.

The most common adverse events (>5%) were nausea, vomiting, diarrhea, abdominal pain and constipation. 

Novo Nordisk intends to make semaglutide available in a pre-filled delivery device based on the same technology platform as FlexTouch.

For more information visit Novonordisk-us.com.