The U.S. Food and Drug Administration approved Novo Nordisk A/S' diabetes drug Ozempic.
Ozempic, or semaglutide, is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
The approval is based on the results from a clinical trial program, in which the drug showed reductions in body weight and also reduced glycated hemoglobin compared with placebo, sitagliptin, exenatide extended-release and insulin glargine U100.
Ozempic will be launched in the latest generation of Novo Nordisk's prefilled devices called Ozempic Pen.
Novo Nordisk will conduct a pediatric trial in adolescents under 18 years of age as part of the post-approval requirements.
