Novo Nordisk submits NDA for its diabetes drug in Japan

February 28, 2017 Off By Dino Mustafić

Novo Nordisk has submitted a New Drug Application (NDA) to the Japanese Ministry of Health, Labour and Welfare for semaglutide, a new glucagon-like peptide-1 (GLP-1) analogue administrated once-weekly, for the treatment of adults with type 2 diabetes.

The Japanese filing follows the recent once-weekly semaglutide regulatory submissions to the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), Health Canada and SwissMedic.

Mads Krogsgaard Thomsen, executive vice president and chief scientific officer of Novo Nordisk said: “Based on the results from the global SUSTAIN clinical trial programme, we believe that once-weekly semaglutide has the potential to improve the treatment for many type 2 patients in Japan.”