Novo Nordisk announced that the US Food and Drug Administration (FDA) has approved Ozempic (semaglutide injection). Ozempic is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus.
Ozempic, the approved brand name for once-weekly semaglutide in the US, is a glucagon-like peptide 1 (GLP-1) receptor agonist. The approval of Ozempic is based on the results from the SUSTAIN clinical trial programme and follows a positive recommendation from an FDA Advisory Committee meeting on 18 October 2017. In people with type 2 diabetes, Ozempic produced clinically meaningful and statistically significant reductions in HbA1c compared with placebo, sitagliptin, exenatide extended-release and insulin glargine U100. Furthermore, in the trials, treatment with Ozempic resulted in statistically significant reductions in body weight. Ozempic demonstrated a safe and well-tolerated profile across the SUSTAIN programme with the most common adverse event being mild to moderate nausea, which diminished over time.
Ozempic is approved for use in two therapeutic dosages, 0.5 mg and 1 mg, and will be launched in the Ozempic Pen, the latest generation of Novo Nordisk prefilled devices.
Novo Nordisk will, as part of the post-approval requirements, conduct a paediatric trial in adolescents under 18 years of age and will add Ozempic® to the 15-year MTC (medullary thyroid carcinoma) registry that is being conducted for all other long-acting GLP-1 products.
“We are very excited about the first approval of Ozempic and look forward to making this important innovation available to people in the US with type 2 diabetes in the beginning of 2018,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer. “Type 2 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.”
Filed Under: Drug Discovery