NN 9535 (semaglutide subcutaneous) filed in EU and US for type 2 diabetes- Novo Nordisk

Novo Nordisk announced the submission of a New Drug Application (NDA) to the FDA and a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for NN 9535 (semaglutide subcutaneous), 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. Across the SUSTAIN clinical trial programme, once-weekly semaglutide had a safe and well tolerated profile with the most common adverse event being nausea.

Comment: Along with NN 9535, the oral daily version of Novo's semaglutide, called OG 217SC, could impact radically on the GLP-1 market. Already, its Victoza daily GLP-1 injection is market leading with $2 billion annual sales.