Novo Nordisk Submits FDA Application for Higher Dose Semaglutide Injection

MT Newswires Live
2025/11/26

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.

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