Novo Nordisk files Europe application for semaglutide for obesity

 

• Novo Nordisk (NYSE:NVO) has submitted a marketing application to the European Medicines Agency for subcutaneous semaglutide 2.4 mg, a once-weekly glucagon-like peptide-1 (GLP-1) analogue for weight management. Potential indication is for the treatment of adults with obesity or overweight with at least one weight-related comorbidity, as an adjunct to reduced-calorie diet and increased physical activity
• Earlier this month, Novo also filed for FDA approval for semaglutide, and applied a priority review to the application, meaning that the anticipated review time will be six months from the submission date.
• Also, Novo Nordisk's another obesity treatment, Saxenda (liraglutide) injection, received FDA nod for expanded use in the treatment of obesity in adolescents (12–17 years). Saxenda was approved in 2014 for chronic weight management in adults.
• Oral semaglutide is already marketed in the EU under the brand name Rybelsus for type II diabetes, as an adjunct to diet and exercise for adults whose condition remains uncontrolled.
• https://seekingalpha.com/news/3645714-novo-nordisk-files-europe-application-for-semaglutide-for-obesity