Semaglutide filed with FDA and EMA for the treatment of type 2 diabetes

5 December 2016

A New Drug Application has been filed with the US Food and Drug Administration for semaglutide, a glucagon-like peptide-1 (GLP-1) analog administered once-weekly, for the treatment of adults with type 2 diabetes.

Danish diabetes care giant Novo Nordisk (NOV: N) also said today that it has submitted a Marketing Authorization Application to the European Medicines Agency for semaglutide.

The submissions are based on the results from the SUSTAIN clinical trial program which included more than 8,000 adults with type 2 diabetes. In the SUSTAIN program, once-weekly semaglutide was studied in combination with oral-antidiabetic agents and in combination with basal insulin.

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