Ozempic (semaglutide) has been cleared as a monotherapy to treat adults with type II diabetes when metformin is considered inappropriate, and also as an addition to other medicinal products to improve glycaemic control.
The drug 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.
As such, the label reflects "the superior and sustained reductions in HbA1c and body weight achieved with Ozempic relative to comparator treatments, cardiovascular benefits and the statistically significant reduction in diabetic nephropathy compared to standard of care," Novo noted.
The launch of Ozempic is expected to take place in the first EU countries in the second half of 2018.
Mads Krogsgaard Thomsen, Novo’s executive vice president and chief science officer, said the firm believes Ozempic has the potential to set a new standard for the treatment of type II diabetes.
“The strong clinical profile of Ozempic provides a much needed treatment option for people looking for efficacious solutions to manage their disease,” he said.
The drug was approved in the US in December.