Posted by Michael Wonder on 07 Dec 2016
Novo Nordisk files for regulatory approval of once-weekly semaglutide in the US and EU for the treatment of type 2 diabetes
5 December 2016 - Novo Nordisk today announced the submission of a new drug application to the US FDA and a marketing authorisation application to the MA for semaglutide, a new glucagon-like peptide-1 (GLP-1) analogue administered once-weekly, for the treatment of adults with type 2 diabetes.
The submission is based on the results from the SUSTAIN clinical trial programme, which included more than 8,000 adults with type 2 diabetes. In the SUSTAIN programme, once-weekly semaglutide was studied in combination with oral-antidiabetic agents and basal insulin. Semaglutide demonstrated statistically significant and sustained blood glucose control compared to sitagliptin, exenatide extended-release, once-daily insulin glargine U100 and placebo. Furthermore, the cardiovascular outcomes trial, SUSTAIN 6, demonstrated a statistically significant cardiovascular risk reduction compared to placebo, as add-on to standard of care in patients with high cardiovascular risk. In addition, semaglutide demonstrated statistically significantly greater reductions in mean body weight versus comparators.
