Novo Nordisk files for regulatory approval of once-weekly semaglutide for the treatment of type 2 diabetes in Japan

Bagsværd, Denmark, 28 February 2017 - Novo Nordisk today announced the submission of 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.

The Japanese submission is based on results from the SUSTAIN clinical trial programme. The SUSTAIN programme involved more than 8,000 adults with type 2 diabetes, with approximately 1,200 participants from Japan. Trial participants were treated with once-weekly semaglutide as monotherapy, or with oral-antidiabetic (OAD) agents or in combination with OADs and basal insulin. Across the SUSTAIN programme, once-weekly semaglutide demonstrated statistically significant reductions in HbA_1c as well as statistically significant reductions in mean body weight compared to sitagliptin, exenatide extended-release, once-daily insulin glargine U100 and placebo. 

Across the SUSTAIN clinical trial programme, once-weekly semaglutide had a well-tolerated safety profile, with the most common adverse event being nausea. 

"We are very excited about having filed the regulatory application for once-weekly semaglutide in Japan," said Mads Krogsgaard Thomsen, executive vice president and chief scientific officer of Novo Nordisk. "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."

Further information

 Company announcement No 15 / 2017