Novo Nordisk seeks US and EU approval for new type 2 diabetes treatment

The company submitted a new drug application (NDA) to the US Food and Drug Administration and a marketing authorisation application to the European Medicines Agency.

Semaglutide works by stimulating insulin and suppressing secretion of glucagon in a glucose-dependent manner, while bringing down appetite and food intake.

Novo Nordisk executive vice president and chief science officer Mads Krogsgaard Thomsen said: “Achieving blood glucose control, weight loss and reducing the risk of cardiovascular events remains a significant challenge for adults with type 2 diabetes.”

Thomsen added that semaglutide has shown the potential to improve the treatment of type 2 diabetes patients further during its clinical trial.

Novo Nordisk's submissions for semaglutide are based on the results of SUSTAIN clinical trial which enrolled over 8,000 type 2 diabetes adult patients.

Semaglutide, which was administered to the subjects weekly once, was assessed in combination with combination with basal insulin and oral-antidiabetic agents during the trial.

The candidate showed statistically and controlled blood glucose throughout the trial in comparison to sitagliptin, exenatide extended-release, once-daily insulin glargine U100 and placebo.

Additionally, semaglutide recorded a statistically significant reduction in cardiovascular risk in comparison to placebo during the SUSTAIN 6 cardiovascular outcomes trial which featured patients having high cardiovascular risk.

It also recorded greater reductions in mean body weight against comparators during the trial.

Novo Nordisk plans to make once-weekly semaglutide available in a prefilled delivery device based on the same technology platform as FlexTouch.