Novo Nordisk (NVO) said Wednesday it has submitted a supplemental new drug application to the Food and Drug Administration for a higher dose semaglutide injection of 7.2 milligrams to be used in combination with a reduced calorie diet and increased physical activity for chronic weight management in adults with obesity.
The company said it expects a review within one or two months following the FDA's acceptance of the filing.
The application includes results from a 72-week phase 3 trial of a once-weekly semaglutide 7.2 mg that showed an average weight loss of 20.7%,
compared to a reduction of 17.5% with semaglutide 2.4 mg and 2.4% with placebo.
The company said that adverse gastrointestinal events were more common with the higher dose of semaglutide.
Shares of the company were up 3.6% in recent premarket activity.