Novo Nordisk gains approval for once per week diabetes drug by FDA
Novo Nordisk has acquired its first global approval for its once-weekly diabetes therapy Ozempic in the US.
The FDA has approved the drug’s use alongside diet and exercise to improve glycaemic control in adults with type II diabetes.
Ozempic is a glucagon-like peptide 1 (GLP-1) receptor agonist that induced clinically meaningful and statistically significant reductions in HbA1c compared with placebo, sitagliptin, exenatide extended-release and insulin glargine U100 in clinical trials.
Statistically significant reductions in body weight were also observed in patients taking the drug during the SUSTAIN clinical trial programme, Novo noted.
“Type II diabetes is a complex disease, but with the unique clinical profile of Ozempic, we believe it has the potential to set a new standard for the treatment of the disease,” noted Mads Krogsgaard Thomsen, Novo’s Executive Vice President and Chief Science Officer.
As part of the post-approval requirements, the company will now carry out paediatric trial in adolescents under 18 years of age and will also add Ozempic to the 15-year MTC (medullary thyroid carcinoma) registry that is being conducted for all other long-acting GLP-1 products.