Novo Nordisk files liraglutide at FDA and EMA for treatment of Obesity
Novo Nordisk has announced two separate regulatory submissions for a 3 mg dose of liraglutide, a once-daily human GLP-1 analogue, as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with Obesity, or who are Overweight with comorbidities.
The company filed a New Drug Application (NDA) with the FDA and a Marketing Authorisation Application (MAA) with the European Medicines Agency (EMA).
The submissions for liraglutide 3 mg include data from the Phase III SCALE clinical trial programme, which involved more than 5,000 people with Obesity or who are Overweight with comorbidities. In addition to the data from the SCALE programme, data from earlier development phases and data related to the use of liraglutide in Type 2 Diabetes were also included in the submissions.
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