Novo Nordisk: files for European approval of obesity drug

(CercleFinance.com) - Novo Nordisk said on Friday that it has filed a new drug application in Europe for its diabetes drug semaglutide, a key milestone as the Danish drugmaker is now seeking approval for the weight management of people living with obesity.


Novo has submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for subcutaneous semaglutide 2.4 mg, once a week, for weight management, it said in a statement.

The indication is for the treatment of obese adults, or who are overweight with at least one weight-related comorbidity, in addition to following a specific diet and a certain level of physical activity.

The filing is based on the results from a phase 3 trial that enrolled 4,500 people, which resulted in a weight loss of 15%-18% for people treated with semaglutide, it said.

The move follows the recent regulatory filing with the FDA in the US.

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